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 :

( 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.

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

AI/ML Overview

The provided 510(k) summary for the Edan Instruments Patient Monitor (Models iM50 and iM80) does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and study proving device performance.

This document is a traditional 510(k) summary, which generally focuses on establishing substantial equivalence to predicate devices rather than providing exhaustive clinical study details. It refers to various internal tests but does not elaborate on their methodologies or results in a way that directly answers your questions.

However, I can extract the information that is present and note where the requested details are missing.

Here's what can be gathered from the provided text:

Acceptance Criteria and Device Performance Study for Edan Instruments Patient Monitor (Models iM50 and iM80)

The provided 510(k) summary does not explicitly state acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it broadly claims that the device has "the same or similar performance specifications" as its predicate devices, implying that it meets the performance established by those already cleared devices.

The document mentions that "Verification and validation testing was done on the Patient Monitor" to demonstrate substantial equivalence. This testing includes:

Software testing
Hardware testing
Safety testing
Environment test
Risk analysis
Final validation

However, no specific study details, quantitative results, or acceptance criteria for these tests are provided in this summary. The summary focuses on comparing the new device's features and operational principles to predicate devices.

Missing Information Details:

1. A table of acceptance criteria and the reported device performance:
* Not available in the provided text. The document states "have the same or similar performance specifications" as predicate devices, but does not list these specifications or the new device's performance against them.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not available in the provided text. The summary mentions "testing," but no details on sample size, data type, or origin are given.

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):
* Not available in the provided text. There is no mention of experts or ground truth establishment for testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not available in the provided text. There is no mention of adjudication methods.

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:
* Not applicable and not available in the provided text. This device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement with AI would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not explicitly detailed in the provided text for specific performance metrics. While "Software testing," "Hardware testing," "Safety testing," and "Final validation" are listed, the specifics of these tests and whether they constitute a "standalone" performance assessment (beyond basic functionality) are not explained. The general statement of "same or similar performance specifications" suggests standalone functions are expected to meet predicate device levels.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not available in the provided text. The document does not specify how ground truth was established for its testing.

8. The sample size for the training set:
* Not applicable and not available in the provided text. This is a traditional patient monitor, not an AI/machine learning device that would typically have a "training set" in the context of algorithm development for complex pattern recognition.

9. How the ground truth for the training set was established:
* Not applicable and not available in the provided text. (See point 8).

In summary, the provided 510(k) submission focuses on demonstrating substantial equivalence through a comparison of features, operating principles, and general performance specifications to legally marketed predicate devices. It does not include the detailed clinical study data, performance metrics, and methodological specifics you've requested beyond general statements of testing being performed. Such detailed information would typically be found in the complete 510(k) submission, not necessarily in the summary intended for public disclosure.

Summary

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K113623

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, 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
------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2011-12-02 Date of Preparation:

Patient Monitor (Models iM50 and iM80 ) Proprietary Name:

Classification:

Description	Classification	Productcode
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 868.1500 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

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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 NIBPoption	K032363	July 30, 2003
Colin Medical Instruments Corp	BX-10	K032857	April.21,2003
PHASEIN AB	Carbon-dioxideanalyzer	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 :

iM50 :

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

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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.

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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

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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

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.