Dictum Health

K152645 · Dictum Health, Inc. · MWI · Feb 9, 2016 · Cardiovascular

Device Facts

• Record ID: K152645
• Device Name: Dictum Health
• Applicant: Dictum Health, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 9, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

IDM100 is an integrated medical tablet for remote patient monitoring and virtual exams; facilitates secure HIPAA-compliant video conferencing between patients and clinicians. Inputs include 12-lead/3-lead ECG, NIBP, tympanic temperature, SpO2, and electronic stethoscope auscultation signals; manual entry for height, weight, and respiratory rate. Device processes and displays vital signs; syncs data with EMR via Oracle DMS Mobile Sync. Used in hospitals, clinics, or homes; operated by clinicians or patients/caregivers. Provides real-time data for clinical decision-making; enables remote diagnosis and consultation. Benefits include expanded access to care for at-risk patients and improved clinical workflow efficiency.

Clinical Evidence

Bench testing only. Clinical evaluation compared 12-lead ECG performance of IDM100 against Welch Allyn CP150 using 18 patients (normal and abnormal). Results showed direct correlation and comparable testing results. Additional bench testing included software validation, transportation simulation, pulse simulator testing for SpO2, tympanic thermometer accuracy, and NIBP evaluation per EN1060-3.

Technological Characteristics

Integrated medical tablet with 10.1-inch capacitive touch screen. Connectivity via WiFi, LAN, USB, and Bluetooth. Powered by rechargeable battery. Diagnostic modules: SunTech Advantage Mini (NIBP), Covidien Genius 2 (Temperature), NellCor Oximax (SpO2). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-49, and IEC 60601-1-11. Software validation performed for Moderate Level of Concern.

Indications for Use

Indicated for neonates, pediatric, adolescent, and adult patients to collect, store, and transmit vital signs data in clinical or remote settings (home/clinic) via secure video conferencing. Not for continuous monitoring.

Regulatory Classification

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.

Predicate Devices

• Tempus IC2 (K152124)

Reference Devices

• Welch Allyn CP150

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 [phone] Fax: [phone] www.dictumhealth.com Date prepared: January 30, 2016 Prepared by: Paul Landesman

- 1. Identification of the Device: Proprietary - Trade Name: IDM100
Common Name: Integrated Medical Tablet

| Classification Names/Product code | Regulation |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Primary: Monitor,Physiological, Patient<br>(Without Arrhythmia Detection Or Alarms) Product Code MWI<br>Other 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 | | | |

- 3. 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.

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.

- 4. 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 |

- 5. Comparison with predicate devices IFU and Technological characteristics

| | Tempus IC2 K152124 | New Device: Dictum Health Inc., IDM100<br>K152645 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | "The Tempus IC2 is intended to aid with the<br>diagnosis of a person presenting as unwell or<br>sick when they are in a location remote from<br>immediate medical assistance. The device<br>allows the User to take vital signs data from a<br>patient and to transmit that data to medical<br>professionals located at the response<br>centre elsewhere. Typical examples are<br>remote land, sea or air locations. The Tempus<br>IC2 is intended primarily to be used by<br>medically unqualified people who have<br>received basic training in the use of the<br>device. Medical expertise is provided through<br>communication with the Response Centre<br>which would be staffed by physicians who | The IDM100 for use by clinicians and patients<br>to collect, store, and transmit general patient<br>health information and patient vital signs<br>data between the patient and a health care<br>professional. The IDM100 is intended for use<br>on neonate (up to 28 days), pediatric (29<br>days to 12 years), adolescent (>12 years &<br><18 years) and adult (18 years and older)<br>populations, in the clinical setting, or a<br>remote location such as home or clinic with<br>the clinician interacting with the patient<br>and/or caregiver using secured video<br>conferencing. The product is not intended<br>for continuous patient monitoring.<br>Vital Sign and Cardiopulmonary Tests: |

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| | Tempus IC2 K152124 | New Device: Dictum Health Inc., IDM100<br>K152645 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | would advise the operator on the nature of<br>the medical incident. The Tempus IC2 is<br>intended to be used where a physician or<br>other medically trained staff may or may not<br>be present but where remote physician<br>support is required. Tempus IC2 measures<br>non-invasive blood pressure, SpO2, pulse<br>rate, respiration rate and ETCO2, 12 Lead<br>ECG, tympanic temperature (via a wireless<br>external module) and blood glucose (via a<br>wireless external module). The Tempus IC2 is<br>suitable for use on adults or children (over 10<br>years old and over 20kg in weight)." | Signal acquisition and display for 12 lead ECG<br>waveform and 3 lead rhythm: for evaluation<br>and diagnosis of patient cardiac function.<br>Non-invasive blood pressure (NIBP):<br>automatically measures systolic and diastolic<br>pressure and pulse rate, as well as calculates<br>an approximate mean arterial pressure<br>(MAP). Patient temperature: provides<br>temperature measurements from the<br>tympanic membrane (ear) and manual entry<br>of oral, rectal and axillary temperatures.<br>SpO2 Oximeter: for the non-invasive<br>measurement of functional oxygen<br>saturation of arterial hemoglobin (SpO2) and<br>pulse rate. Electronic Stethoscope: for<br>acquiring and monitoring of auscultation<br>signals from the attached chest piece.<br>Manual interface for height, weight,<br>respiratory rate, and other manually<br>captured patient information. |
| | Indications are functionally the same except for ETCO2, and blood glucose which we chose not to support at<br>this time. Predicate does not include stethoscope. | |
| External<br>Communication | Ethernet, Wi-Fi, Cellular | Ethernet and Wi-Fi. These two modes are<br>sufficiently ubiquitous to be functionally<br>equivalent to the predicate. |
| User<br>Interface | 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 |
| Environment<br>to be used in | Hospital, Clinic, Home | Hospital, Clinic, Home |
| Dimensions | H 203 mm 7.99" x W 289 mm 2.91" x D 74<br>mm 2.91 " | H: 1.5 in/2.6 cm × W: 8 in/21 cm × L: 10 in/26<br>cm (Designed for portability, more flexible) |

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| | Tempus IC2 K152124 | New Device: Dictum Health Inc., IDM100<br>K152645 |
|--------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Weight, incl.<br>battery | 2.8 kg 6.17 lb. | 3.8 lbs (Lighter) |
| Patient cable<br>and leads | Meets or exceeds ANSI/AAMI EC53, EN/IEC<br>60601-2-25 and EN/IEC 60601-2-51 | Meets or exceeds ANSI/AAMI EC53, EN/IEC<br>60601-2-25 and EN/IEC 60601-2-51 (Same) |
| Protection<br>against<br>electric<br>shock | Class I, internally powered Type CF | Class I, internally powered Type CF (Same) |
| Prescription<br>or OTC | Prescription | Prescription (Same) |
| Additional<br>modes | Not applicable | Electronic stethoscope<br>2 internal HD cameras for medical images<br>and video Video conferencing<br>(More flexible) |
| Power | Rechargeable Battery, 6 hour | Rechargeable Battery, 4.5 hour (Adequate for<br>use, warning message when power reserve is<br>at 20% or lower) |
| Battery<br>Recharge | From AC Line, 6 hours. | From AC Line, < 3 hours. (Faster recharge) |

- 6. 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.
- 7. 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 +<br>CORR. 1 (2006) +<br>CORR. 2 (2007) | Medical electrical equipment – Part 1: General requirements for basic<br>safety and essential performance | 2005 + CORR. 1<br>(2006) + CORR. 2<br>(2007) |
| IEC 60601-1-2 ed3.0<br>(2007-03) | General requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic disturbances - Requirements and<br>tests | ed3.0 (2007-03) |
| IEC 60601-2-25 ed 2.0<br>(2011-10) | Particular requirements for the basic safety and essential performance of<br>electrocardiographs | ed 2.0 (2011-10) |
| IEC 60601-2-49 ed 2.0 | Particular requirements for the basic safety and essential performance of<br>multifunction patient monitoring equipment | ed 2.0 |
| IEC 60601-1-11 | General requirements for basic safety and essential performance -<br>Collateral Standard: Requirements for medical electrical equipment and<br>medical electrical systems used in the home healthcare environment | 1st ed |
| ISTA Procedure 2A<br>(2011)<br>ASTM D4169-14 | Partial Simulation Performance Test Procedure, Packaged-Products 150 lb<br>(68 kg) or Less Standard Practice for Performance Testing of Shipping<br>Containers and Systems | 2011 |

- 8. 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.
- 9. 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.