The iM60 monitor monitors parameters such as ECG (3-lead, 5-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) and 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.

The iM70 monitor monitors parameters such as ECG (3-lead, 5-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.

Device Description

iM60/iM70 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.

iM60 is outfitted with a 10.4-inch display screen, iM70 is I 2.1-inch, as well as an equally large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses.

iM60 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP, TEMP, ECG, RESP, EtCO2, IBP and C.O..

iM70 Patient Monitor has parameter modules including SpO2 with EDAN SpO2 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600, TEMP, ECG, RESP, EtCO2, C.O., IBP, AG.

AI/ML Overview

The provided document is a 510(k) summary for the Edan Instruments iM60 and iM70 Patient Monitors. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a specific study proving the device meets them.

The document states:

"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."
"The iM60 and iM70 Patient Monitors... have the same or similar performance specifications."

However, it does not provide a table of acceptance criteria and reported device performance directly within this document, nor does it describe a specific study (e.g., clinical trial or comparative effectiveness study) with details about sample sizes, ground truth establishment, or expert involvement.

The "Test Summary" section lists general quality assurance measures applied:

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

These are general categories of testing and do not provide the specific performance metrics or the details of a study that would be needed to answer the questions thoroughly.

Therefore,Based on the provided K131971 510(k) summary, the following information can be extracted or is explicitly stated as not available within this document:

Acceptance Criteria and Device Performance

The document does not explicitly state specific numerical acceptance criteria for performance metrics nor does it provide a table of reported device performance against such criteria. It relies on the assertion that the new devices have "the same or similar performance specifications" as the legally marketed predicate devices (Edan Instruments iM50 and iM80, K113623).

Study Details

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

Not provided in this document. The submission relies on demonstrating "substantial equivalence" to predicate devices, implying that the performance is "the same or similar" to the predicate.

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

Not provided in this document. The document mentions "Verification and validation testing" but does not detail the nature of these tests, including sample sizes or data provenance.

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 provided in this document. No information about expert involvement in establishing ground truth for any test set is given.

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

Not provided in this document. No details on adjudication methods for any test set are mentioned.

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/Not provided. This device is a patient monitor, not an AI-assisted diagnostic tool typically evaluated with MRMC studies comparing human reader performance. The document does not describe any such study.

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

Not provided in this document. While performance testing would inherently involve standalone device performance, the document does not detail specific "standalone" studies in the context of typical AI device evaluation. It states "Software testing," "Hardware testing," and "Final validation" were performed.

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

Not provided in this document. The method for establishing ground truth for any testing is not described.

8. The sample size for the training set:

Not provided in this document. Information about a "training set" (implying machine learning/AI development) is not mentioned. The device is described as a patient monitor performing continuous monitoring of physiological parameters.

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

Not applicable/Not provided. No training set for an AI/ML algorithm is mentioned.

In summary: The K131971 document is a 510(k) summary demonstrating substantial equivalence for patient monitors. It lists general testing categories but lacks specific details on performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement, which are typically found in more detailed clinical or performance studies.

Summary

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K 131971 pg 1 of 4

510(k) Summary

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: 86-755-26856469
	Fax:86-755-26882223
	Contact person: Cherry Sun
	Email: sunchen@edan.com.cn

Date of Preparation: 2013-01-20

Proprietary Name:	Patient Monitor (Models iM60 and iM70)
promotion of the first for the first for the first for the first for the first of the first of the first of the first of the first of the first of the first and

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 868.1500 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	II	DSA

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connector)
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

Legally Marketed Predicate Devices:

Manufacturer	Predicate Device	510(k) number	Cleared date
Edan Instruments, Inc	iM50	K113623	Feb.1.2012
Edan Instruments, Inc	iM80	K113623	Feb.1.2012

Device Description: iM60/iM70 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.

iM60 is outfitted with a 10.4-inch display screen, iM70 is I 2.1-inch, as well as an equally large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses.

iM60 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP, TEMP, ECG, RESP, EtCO2, IBP and C.O..

iM70 Patient Monitor has parameter modules including SpO2 with EDAN SpO2 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600, TEMP, ECG, RESP, EtCO2, C.O., IBP, AG.

Comparison with predicate device

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The iM60 and iM70 Patient Monitors have the following similarities to that which previously received 510(k) concurrence:

· have the same indications for use,
· use the same operating principle,
· have the same testing module, e.g. EDAN SpO2 module and Nellcor NELL-1 module.
· have the same or similar performance specifications

In summary, the iM60 and iM70 Patient Monitor described in this submission are substantially equivalent to the predicate device.

Intended Use:

!M60:

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

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

Conclusion:

ং : পর্যন্ত | ;

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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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2014

Edan Instruments, Inc. Ms. Cherry Sun Certification Engineer 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan, Shenzhen, Guangdong 518067 P.R. China

Re: K131971

Trade/Device Name: iM60/iM70 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm Regulatory Class: Class II Product Code: MHX, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, DSA, DSI, MLD Dated: February 7, 2014 Received: February 10, 2014

Dear Ms. Sun:

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. 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 statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Cherry Sun

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); 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

fortfram 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): K 131971

Device Name: Patient Monitor Models iM60 and iM70

!M60:

iM70:

× 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)

Date
21.03.20
10:38:47 -04'00'
for Bram Zuckerman

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.