Dictum Health

K170798 · Dictum Health, Inc. · MWI · Jul 14, 2017 · Cardiovascular

Device Facts

• Record ID: K170798
• Device Name: Dictum Health
• Applicant: Dictum Health, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 14, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The IDM100 is 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, except as noted below), adolescent (between 13 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous 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. ECG calculation of diagnostic measurements is provided for adult patients only. • Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value. • 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), wulse rate, and optional Respiratory Rate. • Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece. • Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP) who is physically with the test subject. Spirometry tests are not to be administered by a patient. • Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be performed by a health care professional (HCP) who is physically with the test subject. . Audiometry tests (hearing tests) are not to be administered by a patient. • Manual interface for height, weight, respiratory rate, and other manually captured patient information.

Device Story

IDM100 is an integrated medical tablet for virtual exams; facilitates secure video conferencing between patients and clinicians. Inputs: 12-lead/3-lead ECG, NIBP, tympanic temperature, SpO2, electronic stethoscope, spirometry, and audiometry. Device captures, displays, and transmits data via secure internet to EMR. Used in hospitals, clinics, or homes; operated by clinicians or patients (with specific limitations for spirometry/audiometry). Provides real-time data access for stakeholders; supports clinical decision-making by enabling remote diagnostic assessment. Benefits include expanded access to care for at-risk patients in remote locations.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software validation (moderate level of concern), transportation simulation (ISTA 2A/ASTM D4169), pulse simulator accuracy, tympanic thermometer accuracy, NIBP evaluation (EN1060-3), usability studies, and validation of added modes (audiometry per ANSI/ASA S3.6-2010, ECG via CSE database/clinical verification, spirometry per ATS/ERS 2005). Biocompatibility testing for patient-contact sensors was satisfactory.

Technological Characteristics

10.1-inch capacitive touch screen tablet; connectivity via WiFi, LAN, Bluetooth, and USB. Powered by rechargeable battery. Diagnostic modules: ECG (Type CF), NIBP, tympanic thermometer, SpO2, electronic stethoscope, spirometer (Honeywell pressure sensor), and audiometer. Complies with IEC 60601-1, 60601-1-2, 60601-2-25, 60601-2-49, and 60601-1-11.

Indications for Use

Indicated for neonate, pediatric (6+ years for spirometry/audiometry), adolescent, and adult patients. Used for collection, storage, and transmission of vital signs and health 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

• IDM100 (K152645)

Reference Devices

• Spirobank G (K072979)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping shapes.

#### 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

July 14, 2017

Dictum Health, Inc. % Daniel Kamm Submission Correspondent Kamm & Associates 8870 Ravello Ct. Naples, Florida 34114

Re: K170798

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, DPS, DRX, DXN, DXQ, FLL, DOA, DOD, BZG, EWO Dated: June 16, 2017 Received: June 16, 2017

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

{1}------------------------------------------------

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.

M.A. Wilhelm

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K170798

Device Name IDM100

#### Indications for Use (Describe)

The IDM100 is 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, except as noted below), adolescent (between 13 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous 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. ECG calculation of diagnostic measurements is provided for adult patients only.

· Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value.

· 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), wulse rate, and optional Respiratory Rate.

· Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece.

· Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP) who is physically with the test subject. Spirometry tests are not to be administered by a patient.

· Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be performed by a health care professional (HCP) who is physically with the test subject. . Audiometry tests (hearing tests) are not to be administered by a patient.

· 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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for Dictum Health. The logo features a circular design with a gradient of colors ranging from yellow to green to blue. In the center of the circle is a large, white letter "D". Below the circle, the word "DICTUMHEALTH" is written in a sans-serif font.

K170798 510(k) Summary As described in 21CFR807.92; K171098 Dictum Health Inc. 255 3rd Street, Suite 102 Oakland, CA 94607 [phone] Fax: [phone] www.dictumhealth.com Date prepared: July 10, 2017

## 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 (Without Arrhythmia Detection Or Alarms)<br>Product Code MWI. Other applicable product codes: DPS , DRX, DXN, DXQ, FLL, DQA, DQD. This submission ADDS: ECG Measurement (DPS), Spirometry (BZG), and Audiometry (EWO) | 870.2300 |

2. Substantially equivalent legally marketed device:

| Manufacturer | Name of the Predicate Device | FDA 510(k) # | Regulation/Product Code |
|--------------------|------------------------------|--------------|-------------------------|
| Dictum Health Inc. | IDM100 | K152645 | 21 CFR 870.2300/MWI |

- 3. Indications for Use (intended use): The IDM100 is 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, except as noted below), adolescent (between 13 years and 17 years) and adult (18 years and older) populations, in the clinical setting, or a remote location such as home, or clinic, with the clinician interacting with the patient and/or caregiver via secured video conferencing. The IDM100 is not intended for continuous 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. ECG calculation of diagnostic measurements is provided for adult patients only.
- . Non-invasive blood pressure (NIBP) automatically measures systolic and diastolic pressure and pulse rate, while calculating mean arterial pressure (MAP). The equation used to calculate MAP provides an approximate value.
- . 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), pulse rate, and optional Respiratory Rate.
- . Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece.
- Spirometry captures, displays, stores, and compares pulmonary function measures and waveforms. The spirometer should only be used with patients able to understand and perform the testing instructions. Indicated for use on pediatric, adolescent, and adult patients only. Patients must be six years of age or older. Administration of the spirometry test must be performed by a health care professional (HCP)who is physically with the test subject. Spirometry tests are not to be administered by a patient.
- Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be six years of age or older. The administration of the hearing test must be

{4}------------------------------------------------

K170798

performed by a health care professional (HCP) who is physically with the test subject. Audiometry tests (hearing tests) are not to be administered by a patient

- Manual interface for height, weight, 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. The IDM100 applications range from routine screening in ambulatory care facilities, to physician offices, hospitals and patient homes with traveling HCP (Health Care Professional) or by the patient (layperson). (See indication of use for limitations.) The diagnostic capabilities are designed for the clinical populations described in the indications, including neonatal, pediatric, and adult.

### 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 with waveform measurements
- 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
- · Spirometer. Spirometry tests are not to be administered by a patient.
- Audiometer. Audiometry tests (hearing tests) are not to be administered by a patient
- 2 internal HD cameras for images and video conferencing

The diagnostic tools other than ECG and Spirometry 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 | K051904 |
| FLL: Patient (Tympanic) temperature | 880.2910 | K060649 |
| DQA: Oximeter, SpO2, pulse rate, respiration rate | 870.2700 | K123581 |
| DQD: Electronic Stethoscope | 870.1875 | K081032 |
| DPS: ECG Measurement | 870.2340 | K062282 |
| BZG: Spirometry | 868.1840 | (This submission) |
| EWO: Audiometery (now exempt) | 874.1050 | N/A |

{5}------------------------------------------------

| | Dictum Health Inc., IDM100 K152645 | New Device: Dictum Health Inc., IDM100 |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The IDM100 for use by clinicians and patients to<br>collect, store, and transmit general patient health<br>information and patient vital signs data between<br>the patient and a health care professional. The<br>IDM100 is intended for use on neonate (up to 28<br>days), pediatric (29 days to 12 years), adolescent<br>(>12 years & <18 years) and adult (18 years and<br>older) populations, in the clinical setting, or a<br>remote location such as home or clinic with the<br>clinician interacting with the patient and/or<br>caregiver using secured video conferencing. The<br>product is not intended for continuous patient<br>monitoring.<br>Vital Sign and Cardiopulmonary Tests:<br>• Signal acquisition and display for 12 lead ECG<br>waveform and 3 lead rhythm: for evaluation and<br>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 an<br>approximate mean arterial pressure (MAP).<br>• Patient temperature: provides temperature<br>measurements from the tympanic membrane (ear)<br>and manual entry of oral, rectal and axillary<br>temperatures.<br>• SpO2 Oximeter: for the non-invasive<br>measurement of functional oxygen saturation of<br>arterial hemoglobin (SpO2) and<br>pulse rate.<br>• Electronic Stethoscope: for acquiring and<br>monitoring of auscultation signals from the<br>attached chest piece.<br>• Manual interface for height, weight, respiratory<br>rate, and other manually captured patient<br>information. | The IDM100 is for use by clinicians and<br>patients to collect, store, and transmit general<br>patient health information and patient vital<br>signs data between the patient and a health<br>care professional. The IDM100 is intended for<br>use on neonate (up to 28 days), pediatric (29<br>days to 12 years, except as noted below),<br>adolescent (between 13 years and 17 years)<br>and adult (18 years and older) populations, in<br>the clinical setting, or a remote location such<br>as home, or clinic, with the clinician<br>interacting with the patient and/or caregiver<br>via secured video conferencing. The IDM100 is<br>not intended for continuous monitoring.<br>Vital Sign and Cardiopulmonary Tests:<br>• Signal acquisition and display for 12 lead<br>ECG waveform and 3-lead rhythm for<br>evaluation and diagnosis of patient cardiac<br>function. ECG calculation of diagnostic<br>measurements is provided for adult<br>patients only.<br>• Non-invasive blood pressure (NIBP)<br>automatically measures systolic and<br>diastolic pressure and pulse rate, while<br>calculating mean arterial pressure (MAP).<br>The equation used to calculate MAP<br>provides an approximate value.<br>• Patient temperature provides temperature<br>measurements from the tympanic<br>membrane (ear) and manual entry of oral,<br>rectal, and axillary temperatures.<br>• SpO2 Oximeter for the non-invasive<br>measurement of functional oxygen<br>saturation of arterial hemoglobin (SpO2),<br>pulse rate, and optional Respiratory Rate.<br>• Electronic Stethoscope for acquiring and<br>monitoring of auscultation signals from the<br>attached chest piece.<br>• Spirometry captures, displays, stores, and<br>compares pulmonary function measures<br>and waveforms. The spirometer should only<br>be used with patients able to understand<br>and perform the testing instructions.<br>Indicated for use on pediatric, adolescent,<br>and adult patients only. Patients must be<br>six years of age or older. Administration of<br>the spirometry test must be performed by a<br>health care professional (HCP) who is |
| K170798 | | |
| | Dictum Health Inc., IDM100 K152645 | New Device: Dictum Health Inc., IDM100 |
| | | physically with the test subject. Spirometry<br>tests are not to be administered by a<br>patient.<br>• Screening hearing test using pure tone<br>method. Indicated for pediatric, adolescent<br>and adult only. Patients must be six years of<br>age or older. The administration of the<br>hearing test must be performed by a<br>health care professional (HCP)who is<br>physically with the test subject. Audiometry<br>tests (hearing tests) are not to be<br>administered by a patient.<br>• Manual interface for height, weight,<br>respiratory rate, and other manually<br>captured patient information. |
| Indications are functionally the same except for added functionality: ECG Measurement, Spirometry, and<br>Audiometry | | |
| External<br>Communication | Ethernet and Wi-Fi. These two modes are<br>sufficiently ubiquitous to be functionally<br>equivalent to the predicate. | Ethernet and Wi-Fi. These two modes are<br>sufficiently ubiquitous to be functionally<br>equivalent to the predicate. |
| User<br>Interface | 800 x 600 10.1 in Capacitive Touch, full color. | 800 x 600 10.1 in Capacitive Touch, full color. |
| Photo | Image: Device 1 | Image: Device 2 |
| Environment<br>to be used in | Hospital, Clinic, Home | Hospital, Clinic, Home |
| Dimensions | H: 1.5 in/2.6 cm × W: 8 in/21 cm × L: 10 in/26<br>cm (Designed for portability, more flexible) | H: 1.5 in/2.6 cm × W: 8 in/21 cm × L: 10 in/26<br>cm (Designed for portability, more flexible) |
| Weight, incl.<br>battery | 3.8 lbs | 3.8 lbs (SAME) |
| 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 shock | Class I, internally powered Type CF | Class I, internally powered Type CF (Same) |
| K170798 | | |
| | Dictum Health Inc., IDM100 K152645 | New Device: Dictum Health Inc., IDM100 |
| Prescription<br>or OTC | Prescription…