(159 days)
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.
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.
Based on the provided text, the device in question is a Patient Monitor (Model: iM50, iM60, iM70, iM80), which monitors various physiological parameters. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study for a novel AI device. Therefore, much of the requested information regarding AI-specific evaluation (e.g., sample size for AI test sets, expert adjudication, MRMC studies, AI effect size, ground truth establishment for training) is not applicable or not present in this 510(k) summary.
However, I can extract information related to the device's self-contained performance testing and regulatory acceptance criteria.
Acceptance Criteria and Device Performance for Patient Monitor (iM Series)
The document primarily relies on bench testing and software verification and validation to demonstrate that the iM series Patient Monitor meets its accuracy specifications and relevant consensus standards, thereby establishing substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in a quantitative table for this specific device in the manner typically seen for novel AI models. Instead, it compares the technical specifications of the subject device to a predicate device and states that "the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards."
The comparison table (pages 5 & 6) implicitly indicates that "acceptance" for the subject device's performance corresponds to ranges/specifications that are identical or comparable to the cleared predicate device.
| Parameter/Feature | Acceptance Criteria (Predicate Device K192514) | Reported Device Performance (Subject Device iM50, iM60, iM70, iM80) | Comparison Result |
|---|---|---|---|
| ECG Module | |||
| Lead Mode | 3, 5, 6, 10 Electrodes | 3, 5, 6, 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 | ±2 mV to ±700 mV | Same |
| Pace Pulse Indicator (Width) | 0.1 ms to 2.0 ms | 0.1 ms to 2.0 ms | Same |
| Pace Pulse Indicator (Ascending time) | 10 $μ$s to 100 $μ$s | 10 $μ$s to 100 $μ$s | Same |
| PVC Range (ADU) | 0 to 300 PVCs/min | 0 to 300 PVCs/min | Same |
| PVC Range (PED/NEO) | 0 to 350 PVCs/min | 0 to 350 PVCs/min | Same |
| HR Measurement Range (ADU) | 15 bpm to 300 bpm | 15 bpm to 300 bpm | Same |
| HR Measurement Range (PED/NEO) | 15 bpm to 350 bpm | 15 bpm to 350 bpm | Same |
| QT Range | 200 ms ~ 800 ms | 200 ms ~ 800 ms | Same |
| QTc Range | 200 ms ~ 800 ms | 200 ms ~ 800 ms | Same |
| $\Delta$ QTc Range | -600 ms ~ 600 ms | -600 ms ~ 600 ms | Same |
| RESP Module | |||
| Principle of Operation | Impedance between RA-LL, RA-LA | Impedance between RA-LL, RA-LA | Same |
| Measurement Range (Adult) | 0 to 120 rpm | 0 to 120 rpm | Same |
| Measurement Range (Pediatric/neonate) | 0 to 150 rpm | 0 to 150 rpm | Same |
| NIBP Module | |||
| Technique | Oscillometry | Oscillometry | Same |
| Measurement Range (Systolic Adult) | 25-290 | 25-290 | Same |
| Measurement Range (Systolic Pediatric) | 25-240 | 25-240 | Same |
| Measurement Range (Systolic Neonate) | 25-140 | 25-140 | Same |
| Measurement Range (Diastolic Adult) | 10-250 | 10-250 | Same |
| Measurement Range (Diastolic Pediatric) | 10-200 | 10-200 | Same |
| Measurement Range (Diastolic Neonate) | 10-115 | 10-115 | Same |
| Measurement Range (Mean Adult) | 15-260 | 15-260 | Same |
| Measurement Range (Mean Pediatric) | 15-215 | 15-215 | Same |
| Measurement Range (Mean Neonate) | 15-125 | 15-125 | Same |
| PR from NIBP Measurement Range | 40 bpm to 240 bpm | 40 bpm to 240 bpm | Same |
| SpO2 Module | |||
| SpO2 Measurement Range | 0% to 100% | 0% to 100% | Same |
| Pulse Rate Measurement Range | 25 to 300 bpm | 25 to 300 bpm | Same |
| 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 | |||
| PA/PAWP Range | -6 to +120 mmHg | -6 to +120 mmHg | Same |
| CVP/RAP/LAP/ICP Range | -10 to +40 mmHg | -10 to +40 mmHg | Same |
| P1/P2 Range | -50 to +300 mmHg | -50 to +300 mmHg | Same |
| C.O. Module | |||
| Technique | Thermodilution Technique | Thermodilution Technique | Same |
| C.O. Measurement Range | 0.1 to 20 L/min | 0.1 to 20 L/min | Same |
| TB Range | 23 °C to 43 °C (73.4 °F to 109.4 °F) | 23 °C to 43 °C (73.4 °F to 109.4 °F) | Same |
| TI Range | -1 °C to 27 °C (30.2 °F to 80.6 °F) | -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 |
| CO2 Measuring Range | 0 mmHg to 150 mmHg (0% to 20%) | 0 mmHg to 150 mmHg (0% to 20%) | Same |
| AwRR Measuring Range | 2 rpm to 150 rpm | 2 rpm to 150 rpm | Same |
| AG Module (EDAN G7) | Not present in primary predicate | CO2, N2O, O2, HAL, ISO, ENF, SEV, DES, AwRR, MAC | Different (but similar to referenced predicate 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 requirement | 100-240V, 50/60Hz | 100-240V, 50/60Hz | Same |
| Rechargeable Battery | Yes | Yes | Same |
Notes on the 'AG Module': The document explicitly states for the AG (Anesthesia Gas) module that its "indication is not present in the primary predicate, but is present in Edan Patient Monitor V series K160981." This implies that while it differs from the immediate primary predicate, it is substantially equivalent to a different, already cleared, predicate device from the same manufacturer.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data or number of tests. The performance data section refers to "functional and system level testing" and "bench testing." This implies testing against specifications and standards rather than a clinical dataset of a specific size.
- Data Provenance: Not specified. Given it's a bench test, it would typically be conducted in a laboratory setting. There's no mention of country of origin for test data, nor whether it's retrospective or prospective patient data, as clinical data was deemed "Not applicable."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physiological monitor, not an AI diagnostic device requiring expert consensus for ground truth on images or signals. The "ground truth" for the device's performance would be derived from calibrated measurement references and established engineering principles in bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this is not an AI diagnostic device relying on human expert review for ground truth.
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. This device is a physiological monitor, not an AI-assisted diagnostic tool that requires human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's performance in terms of its physiological measurements and alarm detection is inherently "standalone" in that it performs these functions without direct human intervention in the measurement process itself, generating outputs for healthcare professionals. The bench testing performed would be considered evaluating this standalone performance against technical specifications and standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance (bench testing), the "ground truth" is based on:
- Calibration standards: Using known, precise inputs (e.g., electrical signals simulating ECG, precise pressures for NIBP, known gas concentrations for CO2/AG) to verify the accuracy of the device's measurements.
- Consensus Standards: Adherence to recognized international standards for medical electrical equipment (e.g., IEC 60601 series, ISO 80601 series). These standards define acceptable performance limits and test methodologies.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML device that requires a "training set" in the conventional sense. The device's algorithms are likely based on established physiological signal processing, not deep learning models trained on large datasets.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI/ML model described.
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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.
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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
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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) 26858736Fax: +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(WithArrhythmia 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 |
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| Monitor, Breathing Frequency | |
|---|---|
| 21 CFR 870.1400Analyzer, Gas, Carbon-Dioxide,Gaseous-Phase | CCK |
| 21 CFR 868.1620Analyzer, Gas, Halothane,Gaseous-Phase (Anesthetic Conc.) | CBS |
| 21 CFR 868.1700Analyzer, Gas, Nitrous-Oxide,Gaseous Phase (Anesthetic Conc.) | CBR |
| 21 CFR 868.1720Analyzer, Gas, Oxygen,Gaseous-Phase | CCL |
| 21 CFR 868.1500Analyzer, Gas, Enflurane,Gaseous-Phase (AnestheticConcentration) | CBQ |
| 21 CFR 868.1500Analyzer, Gas, Desflurane,Gaseous-Phase (AnestheticConcentration) | NHO |
| 21 CFR 868.1500Analyzer, Gas, Isoflurane,Gaseous-Phase (AnestheticConcentration) | NHQ |
| 21 CFR 868.1500Analyzer, Gas, Sevoflurane,Gaseous-Phase (AnestheticConcentration) | NHP |
Regulatory Class: Class II
Predicate Device(s): 3.
-
- Edan Instruments, Inc, Patient Monitor Model X8,X10,X12, K192514 (Primary)
-
- Edan Instruments, Inc, Patient Monitor Model elite V5, elite V6, elite V8, K160981 (Reference)
-
- Shenzhen Mindray Bio-Medical Electronics Co., LTD. BeneVision N Series Patient Monitors, K182075 (Reference)
-
- Philips Medizin Systeme Boeblingen GmbH, Patient Monitor Mx700,
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K182979 (Reference)
- 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.
-
- 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 | (iM50,iM60,iM70,iM80) | (X8,X10,X12) | ComparisonResult |
|---|---|---|---|
| Manufacturer/K# | Current Submission | K192514 | — |
| Intended Use | |||
| Description | The monitors are intended to be used formonitoring, storing, recording, andreviewing of, and to generate alarms for,multiple physiological parameters ofadults and pediatrics. The monitors areintended for use by trained healthcareprofessionals in hospital environments.The monitored physiological parameters | The monitors are intended to beused for monitoring, storing,recording and reviewing of, and togenerate alarms for, multiplephysiological parameters of adults,pediatrics and neonates. Themonitors are intended for use bytrained healthcare professionals in | Different.The AGindication isnot present inthe primarypredicate, butis present inEdan PatientMonitor Vseries |
| include: ECG, respiration (RESP),temperature (TEMP), oxygen saturationof arterial blood (SpO2), pulse rate (PR),non-invasive blood pressure (NIBP),invasive blood pressure (IBP), carbondioxide (CO2), cardiac output (C.O.),and Anaesthesia gas(AG).The arrhythmia detection and STSegment analysis are intended for adultpatients.The monitors are not intended for MRIenvironments. | hospital environments.The monitored physiologicalparameters 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), cardiacoutput (C.O.).The arrhythmia detection and STSegment analysis are intended foradult patients.The monitors are not intended forMRI environments. | K160981 | |
| ECG module | |||
| Lead Mode | 3 Electrodes; 5 Electrodes; 6 Electrodes;10 Electrodes | 3 Electrodes; 5 Electrodes; 6Electrodes; 10 Electrodes | Same |
| Arrhythmiaanalyses | 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, MISSEDBEATS, IRR, VBRADY, PNC, PNP | Same |
| ST valueMeasurementRange | -2.0 mV to +2.0 mV | -2.0 mV to +2.0 mV | Same |
| PacePulse Indicator | Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 $ μ $ s to 100 $ μ $ s | Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 $ μ $ s to 100 $ μ $ s | Same |
| PVCRange | ADU: (0 to 300) PVCs/ minPED/NEO: (0 to 350) PVCs/ min | ADU: (0 to 300) PVCs/ minPED/NEO: (0 to 350) PVCs/ min | Same |
| HRMeasurementrange | ADU: 15 bpm to 300 bpmPED/NEO: 15 bpm to 350 bpm | ADU: 15 bpm to 300 bpmPED/NEO: 15 bpm to 350 bpm | Same |
| QT Analysis | |||
| QT/QTc/ΔQTcmeasurement | QT Range: 200 ms ~ 800 msQTc Range :200ms ~ 800 msΔ QTc Range: -600 ms ~ 600 ms | QT Range: 200 ms ~ 800 msQTc Range :200ms ~ 800 msΔ QTc Range: -600 ms ~ 600 ms | Same |
| RESP module | |||
| PrincipleofOperation | 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 |
| MeasurementRange | Measurement range:Adult Pediatric NeonateSystolic 25-290 25-240 25-140Diastolic 10-250 10-200 10-115Mean 15-260 15-215 15-125 | Measurement range:Adult Pediatric NeonateSystolic 25-290 25-240 25-140Diastolic 10-250 10-200 10-115Mean 15-260 15-215 15-125 | Same |
| PR from NIBP | |||
| Measurementrange | 40 bpm to 240 bpm | 40 to 240 bpm | Same |
| Omron and Suntech NIBP module is the same as K160981 | |||
| SpO2 module(EDAN) | |||
| Measurement | SpO20% to 100% | SpO20% to 100% | Same |
| Range | Pulse Rate25 to 300 bpm | Pulse Rate25 to 300 bpm | Same |
| Nellcor SpO2 module is the same as K160981 | |||
| Temperature module | |||
| Number ofchannels | 2 | 2 | Same |
| MeasurementRange | 0 °C to 50 °C(32 °F to 122 °F) | 0 °C to 50 °C(32 °F to 122 °F) | Same |
| IBP module | |||
| MeasurementRange | PA/PAWP: (-6 to +120) mmHgCVP/RAP/LAP/ICP: (-10 to +40) mmHgP1/P2: (-50 to +300) mmHg | PA/PAWP: (-6 to +120) mmHgCVP/RAP/LAP/ICP: (-10 to +40)mmHgP1/P2: (-50 to +300) mmHg | Same |
| C.O. Module | |||
| Technique | Thermodilution Technique | Thermodilution Technique | Same |
| Measurement range | C.O.: 0.1 to 20L/minTB: 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/minTB: 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 |
| MeasureParameters | 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) | |||
| MeasureParameters | 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 issimilar toDräger AGmodulecleared byK160981 |
| 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 |
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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.
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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
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- . 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.
§ 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.