Who is the manufacturer of Patient Monitor?

Edan Instruments, Inc. filed the 510(k) submission for Patient Monitor (K202336).

What is the FDA product code for Patient Monitor?

MHX. It is classified under 21 CFR 870.1025 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Patient Monitor?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Patient Monitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Patient Monitor

K202336 · Edan Instruments, Inc. · MHX · Jan 23, 2021 · Cardiovascular

Device Facts

Record ID	K202336
Device Name	Patient Monitor
Applicant	Edan Instruments, Inc.
Product Code	MHX · Cardiovascular
Decision Date	Jan 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

Intended Use

The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), and Anaesthesia gas(AG). The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are not intended for MRI environments.

Device Story

Patient monitor (iM50, iM60, iM70, iM80) performs continuous monitoring of physiological parameters; inputs include ECG leads, temperature probes, SpO2 sensors, NIBP cuffs, IBP transducers, CO2/anesthesia gas sensors, and cardiac output thermodilution catheters. Device processes signals to display real-time waveforms and numerical data; performs automated arrhythmia detection and ST-segment analysis; generates visual/audible alarms for abnormal conditions. Used in hospital environments by trained healthcare professionals (physicians, nurses). Output allows clinicians to assess patient status and make timely clinical decisions. Benefits include continuous patient surveillance and early detection of physiological abnormalities.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including functional and system-level validation, electrical safety (ANSI/AAMI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), and adherence to specific performance standards for ECG, NIBP, IBP, SpO2, CO2, and temperature monitoring.

Technological Characteristics

Class II patient monitor; supports multi-parameter sensing (ECG, RESP, NIBP, IBP, SpO2, TEMP, CO2, C.O., AG). Connectivity via Wi-Fi (IEEE 802.11a/b/g/n, 2.4/5 GHz). Power: 100-240V AC or internal rechargeable battery. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25/27/34/49, ISO 80601-2-55/56/61. Software-based analysis for arrhythmia and ST-segment.

Indications for Use

Indicated for monitoring, storing, recording, and reviewing physiological parameters (ECG, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, C.O., AG) in adult and pediatric patients. Arrhythmia detection and ST-segment analysis indicated for adult patients only. Intended for use by trained healthcare professionals in hospital settings. Contraindicated for MRI environments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Edan Instruments, Inc, Patient Monitor Model X8,X10,X12 (K192514)

Reference Devices

Edan Instruments, Inc, Patient Monitor Model elite V5, elite V6, elite V8 (K160981)
Shenzhen Mindray Bio-Medical Electronics Co., LTD. BeneVision N Series Patient Monitors (K182075)
Philips Medizin Systeme Boeblingen GmbH, Patient Monitor Mx700 (K182979)

Related Devices

K110922 — PATIENT MONITOR · Edan Instruments, Inc. · Jul 20, 2011
K171901 — uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 15, 2017
K102040 — PATIENT MONITOR · Guangdong Biolight Meditech Co., Ltd. · Sep 24, 2010
K191106 — C50 and C80 Multi-parameter Patient Monitor · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 13, 2019
K093766 — VITALOGIK 6000/6500 · Mennen Medical , Ltd. · May 7, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 23, 2021 Edan Instruments, Inc. Alice Yang Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 China Re: K202336 Trade/Device Name: 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, DPS, DSI, MLD, DRT, DXN, DSK, FLL, DQA, BZQ, CCK, CBS, CBR, CCL, CBQ, NHO, NHQ, NHP Dated: December 25, 2020 Received: December 28, 2020 Dear Alice Yang: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Jennifer W. Shih -S Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ {3}------------------------------------------------ ## 510(K) Summary ## Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92 | 1. Submitter: | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen, 518122 P.R.China. Tel: +86(0755) 26858736 Fax: +86(0755) 26882223 | |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| Contact person: Preparing date: Alice Yang August 11, 2020 ## 2. Device name and classification: ## Trade Name: Patient Monitor, Model: iM50, iM60, iM70, iM80 Common/Usual Name: Patient Monitor | Classification Name | Product code | |-------------------------------------------------------------------------|-------------------------| | 21 CFR 870.1025 | MHX | | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | | | | Subsequent Product Code | | 21 CFR 868.2375 | DPS | | Electrocardiograph | | | 21 CFR 870.2340 | DSI | | Detector and Alarm, Arrhythmia | | | 21 CFR 870.1025 | MLD | | Monitor, ST Segment with Alarm | | | 21 CFR 870.2300 | DRT | | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | | | 21 CFR 870.1130 | DXN | | System, Measurement, Blood-Pressure, Non-Invasive | | | 21 CFR 870.1110 | DSK | | Computer, Blood-Pressure | | | 21 CFR 880.2910 | FLL | | Thermometer, Electronic, Clinical | | | 21 CFR 870.2700 | DQA | | Oximeter | | | 21 CFR 868.2375 | BZO | {4}------------------------------------------------ | Monitor, Breathing Frequency | | |-----------------------------------------------------------------------------------------------|-----| | 21 CFR 870.1400 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | | 21 CFR 868.1620 Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | | 21 CFR 868.1700 Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | | 21 CFR 868.1720 Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | | 21 CFR 868.1500 Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | | 21 CFR 868.1500 Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | | 21 CFR 868.1500 Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | | 21 CFR 868.1500 Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Regulatory Class: Class II #### Predicate Device(s): 3. - 1) Edan Instruments, Inc, Patient Monitor Model X8,X10,X12, K192514 (Primary) - 2) Edan Instruments, Inc, Patient Monitor Model elite V5, elite V6, elite V8, K160981 (Reference) - 3) Shenzhen Mindray Bio-Medical Electronics Co., LTD. BeneVision N Series Patient Monitors, K182075 (Reference) - 4) Philips Medizin Systeme Boeblingen GmbH, Patient Monitor Mx700, {5}------------------------------------------------ K202336 ## K182979 (Reference) 4. Device Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 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 abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. - 5. Indication for Use The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), and Anaesthesia gas(AG). The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are not intended for MRI environments. ## 6. Predicate Device Comparison The table below compares the indication for use and key technological feature of the subject devices to the predicate device (Patient Monitor Model X8, X10, X12, K160981). | Item | <Subject Device> (iM50,iM60,iM70,iM80) | <Predicate Device> (X8,X10,X12) | Comparison Result | |-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer/K# | Current Submission | K192514 | — | | Intended Use | | | | | Description | The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics. The monitors are intended for use by trained healthcare professionals in hospital environments. The monitored physiological parameters | The monitors are intended to be used for monitoring, storing, recording and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in | Different. The AG indication is not present in the primary predicate, but is present in Edan Patient Monitor V series | | | include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), and Anaesthesia gas(AG). The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are not intended for MRI environments. | hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.). The arrhythmia detection and ST Segment analysis are intended for adult patients. The monitors are not intended for MRI environments. | K160981 | | | ECG module | | | | Lead Mode | 3 Electrodes; 5 Electrodes; 6 Electrodes; 10 Electrodes | 3 Electrodes; 5 Electrodes; 6 Electrodes; 10 Electrodes | Same | | Arrhythmia analyses | ASYSTOLE, VFIB/VTAC, COUPLET, VT > 2, BIGEMINY, TRIGEMINY, VENT, R on T, PVC, TACHY, BRADY, MISSED BEATS, IRR, VBRADY, PNC, PNP | ASYSTOLE, VFIB/VTAC, COUPLET, VT > 2, BIGEMINY, TRIGEMINY, VENT, R on T, PVC, TACHY, BRADY, MISSED BEATS, IRR, VBRADY, PNC, PNP | Same | | ST value Measurement Range | -2.0 mV to +2.0 mV | -2.0 mV to +2.0 mV | Same | | Pace Pulse Indicator | Amplitude: ±2 mV to ±700 mV Width: 0.1 ms to 2.0 ms Ascending time: 10 $ μ $ s to 100 $ μ $ s | Amplitude: ±2 mV to ±700 mV Width: 0.1 ms to 2.0 ms Ascending time: 10 $ μ $ s to 100 $ μ $ s | Same | | PVC Range | ADU: (0 to 300) PVCs/ min PED/NEO: (0 to 350) PVCs/ min | ADU: (0 to 300) PVCs/ min PED/NEO: (0 to 350) PVCs/ min | Same | | HR Measurement range | ADU: 15 bpm to 300 bpm PED/NEO: 15 bpm to 350 bpm | ADU: 15 bpm to 300 bpm PED/NEO: 15 bpm to 350 bpm | Same | | QT Analysis | | | | | | | | | | QT/QTc/ΔQTc measurement | QT Range: 200 ms ~ 800 ms QTc Range :200ms ~ 800 ms Δ QTc Range: -600 ms ~ 600 ms | QT Range: 200 ms ~ 800 ms QTc Range :200ms ~ 800 ms Δ QTc Range: -600 ms ~ 600 ms | Same | | | RESP module | | | | Principle of Operation | Impedance between RA-LL, RA-LA | Impedance between RA-LL, RA-LA | Same | | Measurement | Adult: 0 to 120 rpm | Adult: 0 to 120 rpm | Same | | Range | Pediatric/neonate: 0 to 150 rpm | Pediatric/neonate: 0 rpm to 150rpm | Same | | | NIBP module (EDAN) | | | | Technique | Oscillometry | Oscillometry | Same | | Measurement Range | Measurement range: Adult Pediatric Neonate Systolic 25-290 25-240 25-140 Diastolic 10-250 10-200 10-115 Mean 15-260 15-215 15-125 | Measurement range: Adult Pediatric Neonate Systolic 25-290 25-240 25-140 Diastolic 10-250 10-200 10-115 Mean 15-260 15-215 15-125 | Same | | | PR from NIBP | | | | Measurement range | 40 bpm to 240 bpm | 40 to 240 bpm | Same | | | Omron and Suntech NIBP module is the same as K160981 | | | | | SpO2 module(EDAN) | | | | Measurement | SpO2 0% to 100% | SpO2 0% to 100% | Same | | Range | Pulse Rate 25 to 300 bpm | Pulse Rate 25 to 300 bpm | Same | | | Nellcor SpO2 module is the same as K160981 | | | | | Temperature module | | | | Number of channels | 2 | 2 | Same | | Measurement Range | 0 °C to 50 °C(32 °F to 122 °F) | 0 °C to 50 °C(32 °F to 122 °F) | Same | | IBP module | | | | | Measurement Range | PA/PAWP: (-6 to +120) mmHg CVP/RAP/LAP/ICP: (-10 to +40) mmHg P1/P2: (-50 to +300) mmHg | PA/PAWP: (-6 to +120) mmHg CVP/RAP/LAP/ICP: (-10 to +40) mmHg P1/P2: (-50 to +300) mmHg | Same | | C.O. Module | | | | | Technique | Thermodilution Technique | Thermodilution Technique | Same | | Measurement range | C.O.: 0.1 to 20L/min TB: 23 °Cto 43 °C(73.4 °Fto 109.4 °F) TI: -1 °Cto 27 °C(30.2 °Fto 80.6 °F) | C.O.: 0.1 to 20L/min TB: 23° C to 43 °C(73.4 °F to 109.4 °F) TI: -1 °C to 27 °C(30.2 °F to 80.6 °F) | Same | | CO2 Module | | | | | Intended Patient | Adult, pediatric, neonatal | Adult, pediatric, neonatal | Same | | Measure Parameters | EtCO2, FiCO2, AwRR | EtCO2, FiCO2, AwRR | Same | | Measuring Range | CO2:0 mmHg to 150 mmHg (0 % to 20%) AwRR: 2 rpm to 150 rpm | CO2:0 mmHg to 150 mmHg (0 % to 20%) AwRR: 2 rpm to 150 rpm | Same | | Respironics and Masimo CO2 module are the same as K160981 | | | | | AG module (EDAN G7 module) | | | | | Measure Parameters | CO2、N2O、O2、HAL、ISO、ENF、 SEV、DES、AwRR、MAC | | Edan G7 | | Measuring Range | CO2:0%~15Vol % N2O: 0%~100 Vol % HAL/ISO: 0%-8Vol % ENF: 0%-8 Vol % SEV: 0%-10 Vol % DES: 0%-20 Vol % O2: 0%~100 Vol % AwRR: 2rpm-100rpm | \ | module is similar to Dräger AG module cleared by K160981 | | Masimo and Dräger AG module are the same as K160981 | | | | | WI-FI | | | | | IEEE | 802.11a/b/g/n | 802.11a/b/g/n | Same | | Frequency Band | 2.4 GHz ISM band & 5 G ISM band | 2.4 GHz ISM band & 5 G ISM band | Same | | Power supply | | | | | AC power | | | | | Requirement | 100-240V, 50/60Hz | 100-240V, 50/60 Hz | Same | | Battery | | | | | Rechargeable Battery | Yes | Yes | Same | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness. {9}------------------------------------------------ ## 7. Performance Data: ## Non-clinical data: ## Electrical safety and electromagnetic compatibility (EMC) iM Series Patient Monitors were assessed for conformity with the relevant requirements of the following standards and found to comply: - ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - . IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: electromagnetic disturbances – Requirements and tests. - AIM Standard 7351731 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard ## Performance testing-Bench Edan has conducted functional and system level testing to validate the performance of the devices. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards. - . IEC 60601-1-8:2006 + Am1:2012 Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems - . IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs - . IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment - IEC 80601-2-30:2009+A1:2013 Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers - . IEC 60601-2-34:2011 Medical electrical equipment - part 2-34: particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment - . IEC 60601-2-49:2011 Medical electrical equipment -Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment - . ISO 80601-2-55: 2018 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors - ISO 80601-2-56: 2017+A1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement {10}------------------------------------------------ - . ISO 80601-2-61: 2017 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment - IEEE ANSI C63.27:2017 American National Standard for Evaluation of Wireless Coexistence ## Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". #### Clinical data: Not applicable. #### Summary The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device. ## 8. Conclusion The bench testing data and software verification and validation demonstrate that iM series Patient Monitor are substantially equivalent to the predicate device.