(146 days)
The IDM100 for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years & <18 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home or clinician interacting with the patient and/or caregiver using secured video conferencing. The product is not intended for continuous patient monitoring. Vital Sign and Cardiopulmonary Tests:
Signal acquisition and display for 12 lead ECG waveform and 3 lead rhythm: for evaluation and diagnosis of patient cardiac function.
Non-invasive blood pressure (NIBP): automatically measures systolic and diastolic pressure and pulse rate, as well as calculates an approximate mean arterial pressure (MAP). Patient temperature: provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal and axillary temperatures.
SpO2 Oximeter: for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
Electronic Stethoscope: for acquiring and monitoring of auscultation signals from the attached chest piece.
Manual interface for height, respiratory rate, and other manually captured patient information.
The IDM100 is an integrated medical tablet with diagnostic equipment and secure HIPAA-compliant video conferencing capability facilitating Virtual Exam Rooms (VER) between patients and care providers anywhere. It captures patient vital signs and cardiopulmonary information with clinical accuracy. The IDM100 syncs the data seamlessly with electronic medical records (EMR) providing real-time access for all stakeholders in the continuum of care. The IDM100 transmist the the patient data over a secure internet connection.
The provided document is a 510(k) Summary for the IDM100 device. While it describes various tests performed for safety and effectiveness, it does not clearly present specific acceptance criteria in a table format for performance metrics or a detailed study proving the device meets these criteria in the way typically expected for a detailed clinical performance study report.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Tempus IC2, K152124) by comparing indications for use, technological characteristics, and by performing various verification and validation tests against recognized standards.
Here's an attempt to extract and synthesize the requested information based on the provided text, highlighting where information is not explicitly available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by conformity to specific standards and satisfactory results from various tests, rather than explicit numerical thresholds given in a table. The document focuses on demonstrating that the IDM100's components meet established standards for similar devices or that its overall performance is comparable to a predicate device.
| Performance Metric / Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Validation & Risk Assessment | Compliance with FDA guidelines for Moderate Level of Concern | Results were satisfactory. |
| Transportation Simulation Evaluation | Meet ISTA Procedure 2A (2011) and ASTM D4169-14 standards | Results were satisfactory. (Performed by DDL) |
| Simulated Low Perfusion Saturation & Pulse Rate Accuracy | Accuracy as per relevant standards (not explicitly stated) | Results were satisfactory. |
| Tympanic Thermometer Accuracy | Compliance with relevant standard (not explicitly stated) | Results were satisfactory. |
| NIBP Device Evaluation | Compliance with EN1060-3 | Results were satisfactory. (Visual inspections and testing) |
| Design Validation (Usability Study) | Demonstrate usability for intended clinical and non-clinical use | Satisfactory. |
| ECG Function (12-lead) | Comparable to predicate device (Welch Allyn CP150) | Direct correlation between IDM100 and Welch Allyn CP150. Achieving Substantial Equivalence. |
| ECG Function (3-lead) | Safety and accuracy per IEC 60601-02-25 | Passing IEC 60601-02-25 confirms safety and accuracy. (No direct comparison to predicate possible). |
| General Safety and Essential Performance | Compliance with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) | Device complies. |
| Electromagnetic Disturbances | Compliance with IEC 60601-1-2 ed3.0 (2007-03) | Device complies. |
| ECG Particular Requirements | Compliance with IEC 60601-2-25 ed 2.0 (2011-10) | Device complies. |
| Multifunction Patient Monitoring | Compliance with IEC 60601-2-49 ed 2.0 | Device complies. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 1st ed | Device complies. |
2. Sample Size Used for the Test Set and Data Provenance
- ECG Clinical Testing:
- Sample Size: "18 normal and abnormal ECG patients" were compared for the 12-lead ECG function.
- Data Provenance: Not specified (e.g., country of origin). It's described as a "clinical evaluation," suggesting prospective data collection for this specific comparison, but this is not explicitly stated.
- Other Tests (e.g., Low Perfusion, Tympanic Thermometer, NIBP): Sample sizes are not mentioned. These appear to be bench or lab-based tests rather than patient studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- ECG Clinical Testing: The document states that the IDM100 and the Welch Allyn CP150 (predicate) "provide comparable testing result, with no impact to the interpretation of the patients ECG." This implies that the interpretation was assessed, likely by experts, but the number and specific qualifications of these experts are not provided.
- Other Tests: Ground truth for these tests would typically be established by calibrated instruments or reference standards, not human experts in the conventional sense.
4. Adjudication Method for the Test Set
- ECG Clinical Testing: An explicit adjudication method (e.g., 2+1, 3+1) is not described. The statement "no impact to the interpretation of the patients ECG" suggests an expert review or comparison, but the process is not detailed.
- Other Tests: Adjudication methods are not applicable for these types of technical compliance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus human readers without AI assistance, was not mentioned or described in this document. The device itself is a vital signs monitor and data collection system, not an AI interpretation device that assists human readers in diagnostic tasks.
6. Standalone (Algorithm Only) Performance Study
- This device is not an algorithm that provides standalone diagnostic interpretations; it's a medical tablet integrating various diagnostic tools. Therefore, a standalone algorithm performance study, as typically understood for AI/ML devices, was not performed or described. The components (e.g., ECG, NIBP, SpO2) within the IDM100 undergo their own performance evaluations against standards, which implicitly represent their "standalone" capability. The statement "Passing IEC 60601-02-25 confirms the safety and accuracy for IDM100 12-lead and 3-lead IDM ECG testing" relates to the standalone performance of the ECG module.
7. Type of Ground Truth Used
- ECG Clinical Testing: The ground truth for the "normal and abnormal ECG patients" is implicitly their clinical presentation/diagnosis as determined by standard clinical practice and the predicate device's output, which the IDM100 was compared against. It's a comparison to a predicate device's output and clinical interpretation, rather than de novo gold standard like pathology or long-term outcomes.
- Other Tests (e.g., Tympanic Thermometer, NIBP): The ground truth for these tests comes from calibrated reference standards as defined by the respective international standards (e.g., EN1060-3 for NIBP).
8. Sample Size for the Training Set
- This document describes a medical device integrating existing, FDA-cleared diagnostic components and a tablet interface for data collection and transmission. It does not mention the use of a machine learning or AI algorithm that would require a distinct "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
- As the document does not describe the use of a machine learning or AI algorithm requiring a training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Dictum Health, Inc. % Daniel Kamm Submission Correspondent Kamm & Associates 8870 Ravello Ct Naples, Florida 34114
Re: K152645
Trade/Device Name: IDM100 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: January 5. 2016 Received: January 8, 2016
Dear Daniel Kamm:
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 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
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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 Industry and Consumer Education 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. 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/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 Industry and Consumer Education 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 vours
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K152645
Device Name IDM100
Indications for Use (Describe)
The IDM100 for use by clinicians and patients to collect, store, and transmit general patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home or clinician interacting with the patient and/or caregiver using secured video conferencing. The product is not intended for continuous patient monitoring. Vital Sign and Cardiopulmonary Tests:
• Signal acquisition and display for 12 lead ECG waveform and 3 lead thythm: for evaluation and diagnosis of patient cardiac function.
· Non-invasive blood pressure (NIBP): automatically measures systolic and diastolic pressure and pulse rate, as well as calculates an approximate mean arterial pressure (MAP).
· Patient temperature: provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal and axillary temperatures.
· SpO2 Oximeter: for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
· Electronic Stethoscope: for acquiring and monitoring of auscultation signals from the attached chest piece.
· Manual interface for height, weight, respiratory rate, and other manually captured patient information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Dictum Health. The logo is a circle with a gradient of colors, ranging from green to blue. In the center of the circle is a large, white letter "D". Below the circle is the word "DICTUMHEALTH" in blue, all-caps lettering. The logo is simple and modern, and the colors are bright and eye-catching.
510(k) Summary As described in 21CFR807.92 for K152645 Dictum Health Inc. 255 3rd Street, Suite 102 Oakland, CA 94607 (510) 295-4450 Fax: (510) 246-3293 www.dictumhealth.com Date prepared: January 30, 2016 Prepared by: Paul Landesman
-
- Identification of the Device: Proprietary - Trade Name: IDM100
Common Name: Integrated Medical Tablet
- Identification of the Device: Proprietary - Trade Name: IDM100
| Classification Names/Product code | Regulation |
|---|---|
| Primary: Monitor,Physiological, Patient(Without Arrhythmia Detection Or Alarms) Product Code MWIOther applicable product codes: DPS , DRX, DXN, DXQ, FLL, DQA, DQD. | 870.2300 |
2. Substantially equivalent legally marketed device:
| Manufacturer | Name of the Predicate Device | FDA 510(k) # | Regulation/Product Code |
|---|---|---|---|
| Remote Diagnostics | Tempus IC2 | K152124 | 21 CFR 870.2300/MWI |
| Technologies LTD |
-
- Indications for Use (intended use): The IDM100 for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years & <18 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home or clinician interacting with the patient and/or caregiver using secured video conferencing. The product is not intended for continuous patient monitoring. Vital Sign and Cardiopulmonary Tests:
Signal acquisition and display for 12 lead ECG waveform and 3 lead rhythm: for evaluation and diagnosis of patient cardiac function.
- Indications for Use (intended use): The IDM100 for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years & <18 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home or clinician interacting with the patient and/or caregiver using secured video conferencing. The product is not intended for continuous patient monitoring. Vital Sign and Cardiopulmonary Tests:
Non-invasive blood pressure (NIBP): automatically measures systolic and diastolic pressure and pulse rate, as well as calculates an approximate mean arterial pressure (MAP). Patient temperature: provides temperature measurements from the tympanic membrane (ear) and manual entry of oral, rectal and axillary temperatures.
SpO2 Oximeter: for the non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
Electronic Stethoscope: for acquiring and monitoring of auscultation signals from the attached chest piece.
Manual interface for height, respiratory rate, and other manually captured patient information.
-
- Description of the device: The IDM100 is an integrated medical tablet with diagnostic equipment and secure HIPAA-compliant video conferencing capability facilitating Virtual Exam Rooms (VER) between patients and care providers anywhere. It captures patient vital signs and cardiopulmonary information with clinical accuracy. The IDM100 syncs the data seamlessly with electronic medical records (EMR) providing real-time access for all stakeholders in the continuum of care. The IDM100 transmist the the patient data over a secure internet connection.
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SYSTEM FEATURES
- Easy-to-use, 10.1 in/25.7 cm, high-resolution capacitive touch screen
- Lightweight, portable. Less than 4 pounds with battery.
- Secure audio/video conferencing and image capture while streaming data
- Expanded support for point-of care devices with 3 USB ports and Bluetooth
- Connects through WiFi, LAN,
- Oracle™ DMS Mobile Sync provides secure, fast data transfer
- Over 4.5 hours battery usage
Diagnose, monitor, and consult with even the most at-risk patients from virtually anywhere. DIAGNOSTIC TOOLS
- 3 & 12-lead diagnostic resting ECG
- NIBP with MAP and heart rate (SunTech Advantage Mini module)
- Covidien Genius 2™ Tympanic Temperature
- NellCor Oximax™ SpO2 with respiratory and pulse rate
- Electronic stethoscope with CD-quality audio
- 2 internal HD cameras for images and video conferencing
The diagnostic tools other than ECG are implemented via modules and accessories which have all had previous FDA clearances:
| Device Product Code and Name: | Regulation | Clearance |
|---|---|---|
| DRX: Electrode, Electrocardiograph (now exempt) | 870.2360 | K000690 |
| DXN: Noninvasive blood pressure (NIBP) | 870.1130 | K151071 |
| DXQ: Blood Pressure Cuff | 870.1120 | K112544 |
| FLL: Patient (Tympanic) temperature | 880.2910 | K060649 |
| DQA: Oximeter, SpO2, pulse rate, respiration rate | 870.2700 | K123581 |
| DQD: Electronic Stethoscope | 870.1875 | K081032 |
-
- Comparison with predicate devices IFU and Technological characteristics
| Tempus IC2 K152124 | New Device: Dictum Health Inc., IDM100K152645 | |
|---|---|---|
| Indications for Use | "The Tempus IC2 is intended to aid with thediagnosis of a person presenting as unwell orsick when they are in a location remote fromimmediate medical assistance. The deviceallows the User to take vital signs data from apatient and to transmit that data to medicalprofessionals located at the responsecentre elsewhere. Typical examples areremote land, sea or air locations. The TempusIC2 is intended primarily to be used bymedically unqualified people who havereceived basic training in the use of thedevice. Medical expertise is provided throughcommunication with the Response Centrewhich would be staffed by physicians who | The IDM100 for use by clinicians and patientsto collect, store, and transmit general patienthealth information and patient vital signsdata between the patient and a health careprofessional. The IDM100 is intended for useon neonate (up to 28 days), pediatric (29days to 12 years), adolescent (>12 years &<18 years) and adult (18 years and older)populations, in the clinical setting, or aremote location such as home or clinic withthe clinician interacting with the patientand/or caregiver using secured videoconferencing. The product is not intendedfor continuous patient monitoring.Vital Sign and Cardiopulmonary Tests: |
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| Tempus IC2 K152124 | New Device: Dictum Health Inc., IDM100K152645 | |
|---|---|---|
| would advise the operator on the nature ofthe medical incident. The Tempus IC2 isintended to be used where a physician orother medically trained staff may or may notbe present but where remote physiciansupport is required. Tempus IC2 measuresnon-invasive blood pressure, SpO2, pulserate, respiration rate and ETCO2, 12 LeadECG, tympanic temperature (via a wirelessexternal module) and blood glucose (via awireless external module). The Tempus IC2 issuitable for use on adults or children (over 10years old and over 20kg in weight)." | Signal acquisition and display for 12 lead ECGwaveform and 3 lead rhythm: for evaluationand diagnosis of patient cardiac function.Non-invasive blood pressure (NIBP):automatically measures systolic and diastolicpressure and pulse rate, as well as calculatesan approximate mean arterial pressure(MAP). Patient temperature: providestemperature measurements from thetympanic membrane (ear) and manual entryof oral, rectal and axillary temperatures.SpO2 Oximeter: for the non-invasivemeasurement of functional oxygensaturation of arterial hemoglobin (SpO2) andpulse rate. Electronic Stethoscope: foracquiring and monitoring of auscultationsignals from the attached chest piece.Manual interface for height, weight,respiratory rate, and other manuallycaptured patient information. | |
| Indications are functionally the same except for ETCO2, and blood glucose which we chose not to support atthis time. Predicate does not include stethoscope. | ||
| ExternalCommunication | Ethernet, Wi-Fi, Cellular | Ethernet and Wi-Fi. These two modes aresufficiently ubiquitous to be functionallyequivalent to the predicate. |
| UserInterface | LCD Color Touch Screen | 800 x 600 10.1 in Capacitive Touch, full color. |
| Photo | Image: Tempus IC2 K152124 | Image: New Device: Dictum Health Inc., IDM100 K152645 |
| Environmentto be used in | Hospital, Clinic, Home | Hospital, Clinic, Home |
| Dimensions | H 203 mm 7.99" x W 289 mm 2.91" x D 74mm 2.91 " | H: 1.5 in/2.6 cm × W: 8 in/21 cm × L: 10 in/26cm (Designed for portability, more flexible) |
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| Tempus IC2 K152124 | New Device: Dictum Health Inc., IDM100K152645 | |
|---|---|---|
| Weight, incl.battery | 2.8 kg 6.17 lb. | 3.8 lbs (Lighter) |
| Patient cableand leads | Meets or exceeds ANSI/AAMI EC53, EN/IEC60601-2-25 and EN/IEC 60601-2-51 | Meets or exceeds ANSI/AAMI EC53, EN/IEC60601-2-25 and EN/IEC 60601-2-51 (Same) |
| Protectionagainstelectricshock | Class I, internally powered Type CF | Class I, internally powered Type CF (Same) |
| Prescriptionor OTC | Prescription | Prescription (Same) |
| Additionalmodes | Not applicable | Electronic stethoscope2 internal HD cameras for medical imagesand video Video conferencing(More flexible) |
| Power | Rechargeable Battery, 6 hour | Rechargeable Battery, 4.5 hour (Adequate foruse, warning message when power reserve isat 20% or lower) |
| BatteryRecharge | From AC Line, 6 hours. | From AC Line, < 3 hours. (Faster recharge) |
-
- Safety and Effectiveness: The IDM100 labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via the company's design control and risk management procedures. Potential hazards are controlled via development and verification and validation testing. The comparison table above shows substantial equivalence. Additional modes are provided via FDA cleared medical devices.
-
- Testing Information and Performance: The following testing has been successfully performed and documented:
- a. Software Validation and Risk Assessment per FDA guidelines for the Moderate Level of Concern.
- b. Transportation Simulation Evaluation Testing: One packaged IDM100 Integrated Medical Tablet was sent to DDL for transportation simulation evaluation per the following standards listed in the table below. Results were satisfactory.
- c. Simulated Low Perfusion Saturation And Pulse Rate Accuracy Study Using A Pulse Simulator. Results were satisfactory.
- d. Tympanic Thermometer standard Compliance: Accuracy testing. Results were satisfactory.
- e. NIBP Device Evaluation Testing: Visual inspections and testing to EN1060-3, Noninvasive sphygmomanometers - Part 3: Supplementary requirements for electromechanical blood pressure measuring systems; Results were satisfactory.
- f. Design validation (usability study) for the IMD100 indications for use in clinical and nonclinical settings.
- Standards testing protocols per the following list of standards: 8.
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| Standards No. | Standards Title | Version |
|---|---|---|
| IEC 60601-1: 2005 +CORR. 1 (2006) +CORR. 2 (2007) | Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance | 2005 + CORR. 1(2006) + CORR. 2(2007) |
| IEC 60601-1-2 ed3.0(2007-03) | General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements andtests | ed3.0 (2007-03) |
| IEC 60601-2-25 ed 2.0(2011-10) | Particular requirements for the basic safety and essential performance ofelectrocardiographs | ed 2.0 (2011-10) |
| IEC 60601-2-49 ed 2.0 | Particular requirements for the basic safety and essential performance ofmultifunction patient monitoring equipment | ed 2.0 |
| IEC 60601-1-11 | General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment andmedical electrical systems used in the home healthcare environment | 1st ed |
| ISTA Procedure 2A(2011)ASTM D4169-14 | Partial Simulation Performance Test Procedure, Packaged-Products 150 lb(68 kg) or Less Standard Practice for Performance Testing of ShippingContainers and Systems | 2011 |
-
- Clinical Testing: Although not required for a determination of substantial equivalence, clinical evaluation was performed to demonstrate performance equivalence to the predicate for the ECG function. The testing can be summarized this way: We compared 18 normal and abnormal ECG patients to the predicate ECG device. The IDM100 and the Welch Allyn CP150 (predicate) provide comparable testing result, with no impact to the interpretation of the patients ECG. There was no day-to-day or unit-to-unit variation observed in the IDM100 testing. There is no direct comparison between the 12-lead and 3-lead test. The 12-lead ECG test results are comparable between the IDM100 and the CP150 (Predicate Device). SUMMARY CONCLUSION: Testing showed a direct correlation between the IDM100 and Welch Allyn CP150, achieving Substantial Equivalence. The Predicated Device does not have an indication for use for 3-lead ECG testing. The IDM100 3-lead ECG test could not be evaluated against the Predicate Device. Passing IEC 60601-02-25 confirms the safety and accuracy for IDM100 12-lead and 3-lead IDM ECG testing.
-
- Conclusion: The IDM100 has the same intended use as the predicate device. Test results demonstrate that the device is safe, effective, and does not raise any new potential safety risks. In all material respects, the IDM100 is substantially equivalent to the predicate device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).