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 defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

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.

AI/ML Overview

This document is a 510(k) summary for a traditional patient monitor, not an AI/ML device. Therefore, the detailed information typically required for an AI/ML study, such as acceptance criteria, sample sizes for training/test sets, expert qualifications, and specific AI/ML performance metrics, is not present. This submission focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing, not on new algorithm performance.

Here's an analysis of the provided text based on the questions, acknowledging the limitations for an AI/ML context:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, there are no specific quantitative "acceptance criteria" or "reported device performance" metrics explicitly stated in a table format as one would expect for an AI/ML device's efficacy study. The document focuses on establishing substantial equivalence to predicate devices for several physiological parameters.

The closest we get to "performance" is the statement: "have the same or similar performance specifications" in the comparison with predicate devices. This implies that the device is expected to perform at least comparably to the legally marketed predicate devices without detailing specific numerical targets.

The device description mentions it "can perform long-time continuous monitoring of multiple physiological parameters" and "is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity." These are functional descriptions rather than quantifiable performance metrics with acceptance criteria.

Note: For a traditional medical device like a patient monitor, "acceptance criteria" would typically refer to accuracy, precision, and range specifications for each physiological parameter (e.g., NIBP accuracy within ±X mmHg, SpO2 accuracy within ±Y%) as measured against a gold standard. These details are not elaborated in this 510(k) summary; instead, they are covered by demonstrating equivalence to predicate devices which have already met such benchmarks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided text does not specify any sample size for testing. It mentions "Verification and validation testing was done on the Patient Monitor" and lists types of tests like "Software testing," "Hardware testing," "Safety testing," "Environment test," and "Risk analysis." However, it does not detail the methodology, subject count, or data provenance (country, retrospective/prospective) for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As this is a traditional patient monitor, the "ground truth" for physiological measurements would typically be established through direct comparison with reference instruments or clinical standards, rather than expert consensus on interpreted data as might be the case for an AI/ML diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Given it's a traditional device focusing on measurement accuracy and functional safety, an adjudication method like 2+1 or 3+1 (common for expert review in AI/ML studies) would generally not be applicable.

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, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted diagnostic or interpretive devices where human performance with and without AI is compared. The Edan Instruments patient monitor is a traditional monitoring device, not an AI/ML system, and therefore, this type of study is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a "standalone" patient monitor in the sense that its measurements and alarms are generated by the device's inherent algorithms and sensors. However, this is not "standalone (algorithm only without human-in-the-loop performance)" in the context of an AI/ML diagnostic or interpretive algorithm. The monitor is designed to be used "under regular supervision of clinical personnel," meaning a human is always in the loop to respond to the monitor's output. The document does not describe performance of the algorithms in isolation from the full device system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used. However, for a device measuring physiological parameters like ECG, SpO2, NIBP, TEMP, and CO2, the ground truth would typically be established using:

Reference instruments/gold standard devices: For parameters like blood pressure, temperature, and SpO2, highly accurate and calibrated reference devices would be used for comparison.
Physiological simulators or controlled environments: To test accuracy across various conditions.
Clinical observations/direct physiological measurements: For ECG and respiration, direct physiological signals from subjects or phantoms would be compared to the device's interpretation.

8. The sample size for the training set

This information is not provided and is not applicable in the context of this traditional patient monitor 510(k) submission. "Training sets" are specific to AI/ML development, which this device does not appear to utilize in the sense of a learning algorithm.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for the reasons stated above (traditional device, no mention of AI/ML training).

Summary

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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, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: 86-755-26882220Fax:86-755-26882223Contact person: Randy Jiang
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2011-12-09 Date of Preparation:

Patient Monitor Models iM8,iM8A, iM8B Proprietary Name:

Classification:

Description	Classification	Productcode
21 CFR 870.1025 Arrhythmia detector and alarm (Including ST-segmentmeasurement 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 withProbe	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

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Device Description:

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 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 setby the operator, or both.
Contraindications:	It is not intended for use in patient's home or residence, or whenhas not been ordered by a physician.
Test Summary:	The following quality assurance measures were applied to thedevelopment 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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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

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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

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Section 1

Indication for Use

510(k) Number (if known):

K113653

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 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

Regulation Number and Section

§ 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.