(56 days)
Not Found
No
The summary describes a standard patient monitor with basic physiological parameter monitoring, storage, display, and alarming capabilities. There is no mention of AI, ML, or any advanced analytical techniques that would suggest the use of such technology.
No
The device is a patient monitor, designed to observe and display physiological parameters, and generate alarms, but it does not directly treat or restore health.
No.
The device is a patient monitor used for continuous monitoring of multiple physiological parameters, such as ECG, respiration, SpO2, blood pressure, temperature, and CO2, and it indicates alarms for abnormalities. While it provides data for clinicians, it does not explicitly state that it performs a diagnostic function such as identifying or confirming a disease.
No
The device description explicitly states it is a "Patient Monitor" and mentions features like screen size, build-in battery power, and the ability to monitor multiple physiological parameters, all of which indicate a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the device is a "Patient Monitor" that monitors physiological parameters such as ECG, Respiration, SpO2, Blood Pressure, Temperature, and CO2. These are measurements taken directly from the patient's body using sensors and electrodes.
- Intended Use: The intended use is for monitoring patients in a hospital environment and during transport. This involves real-time monitoring of vital signs, not the analysis of samples taken from the patient.
The device is a patient monitoring system, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The monitor monitors parameters such as ECG (3-lead or 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2.
The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility.
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.
Product codes (comma separated list FDA assigned to the subject device)
MHX, DRT, DXN, DSK, FLL, DQA, CCK, DSA, DSI
Device Description
iM8 Series 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. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models.
iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement.
iM8 Series patient monitor includes three models iM8, iM8B, from the view of the below table, screen size is the primary difference for three models.
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
adult, pediatric, and neonatal
Intended User / Care Setting
clinical personnel, hospital environment and during patient transport inside a healthcare facility.
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)
The following quality assurance measures were applied to the development of the Patient Monitor Software testing Hardware testing Safety testing Environment test Risk analysis Final validation. 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.
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.
Not Found
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 K113653
Section l
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 |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
2011-12-09 Date of Preparation:
Patient Monitor Models iM8,iM8A, iM8B Proprietary Name:
Classification:
| Description | Classification | Product
code |
|-----------------------------------------------------------------------------------------------|----------------|-----------------|
| 21 CFR 870.1025 Arrhythmia detector and alarm (Including ST-segment
measurement and alarm) | II | MHX |
| 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 868.2900 cable, transducer and electrode, patient, (including connector) | II | DSA |
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | II | DSI |
Regulatory Class:_ Class II
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 | K102835 | Dec.27.2010 |
| Edan Instruments, Inc | M3B | K083821 | May.14.2009 |
Page 1 of 3
1
Device Description:
iM8 Series 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. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models.
iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement.
iM8 Series patient monitor includes three models iM8, iM8B, from the view of the below table, screen size is the primary difference for three models.
| Product models | Size (L×W×H) | Screen size | Monitoring features |
|---|---|---|---|
| iM8 | 12.1-inch | ||
| iM8A | 320mm×150mm×265mm | 10.4-inch | ECG/RESP, SpO2, NIBP, TEMP, IBP,CO2 |
| iM8B | 10.1-inch Width_screen |
Comparison with predicate device
The iM8 Series 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 iM8 Series Patient Monitor described in this submission is, in our opinion, substantially equivalent to the predicate device
Intended Use:
The monitor monitors parameters such as ECG (3-lead or 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or non-invasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2.
The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility.
The monitor is equipped with alarms that indicate system faults (such as loose or
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| Patient Monitor | |
|---|---|
| Traditional 510K Submission | Section |
| defective electrodes), physiologic parameters that have exceeded the limits set | |
| by the operator, or both. | |
| Contraindications: | It is not intended for use in patient's home or residence, or when |
| 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 Safety testing Environment test Risk analysis Final validation |
Verification and validation testing was done on the Patient Monitor. This Conclusion: premarket notification submission demonstrates that Patient Monitor is substantially equivalent to the predicate device.
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2 page of 3
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Image /page/3/Picture/0 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.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002
Edan Instruments, Inc. c/o Mr. Randy Jiang Certification Engineer 3/F-B, Nanshan Medical Equipment Park, Nanhai Rd., 1019 No. Shenzhen CHINA 518067
FEB - 6 2012
Re: K113653
Trade/Device Name: Patient Monitor, Models iM8, iM8A, and iM8B 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, DSA, and DSI Dated: November 12, 2011 Received: December 12, 2011
Dear 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.
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
4
Page 2 - Mr. Randy Jiang
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, MD
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 1
Indication for Use
510(k) Number (if known):
Device Name: Patient Monitor Models iM8 , iM8A, iM8B
The monitor monitors parameters such as ECG (3-lead or 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2.
The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility.
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.
× 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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K113653