(119 days)
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 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.
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.
Here's the information regarding the IDM100 device's acceptance criteria and the study that proves it meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Spirometry | According to American Thoracic Society (ATS) Standards, particularly ATS/ERS Task Force Standardisation of Lung Function Testing: Standardisation of spirometry (2005) | Results obtained were within the range of accuracy required by ATS. |
| Audiometry | ANSI/ASA S3.6-2010: Specification for Audiometers | Results were satisfactory. |
| ECG Measurements | CSE Database Verification and Clinical Verification | Results were satisfactory (implicit, as "validated"). |
| NIBP Device Evaluation | EN1060-3, Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems | Results were satisfactory. |
| Tympanic Thermometer | Accuracy testing | Results were satisfactory. |
| Low Perfusion SpO2/Pulse Rate Accuracy | Simulated Low Perfusion Saturation and Pulse Rate Accuracy Study | Results were satisfactory. |
| Software Validation | FDA guidelines for the Moderate Level of Concern | Successfully performed and documented. |
| Transportation Simulation | ISTA Procedure 2A (2011), ASTM D4169-14 | Results were satisfactory. |
| Biocompatibility | Cytotoxicity, irritation, and sensitization for the patient contact sensor | Test reports obtained and reviewed were satisfactory. |
| Usability | Human factors usability testing | Successfully conducted. |
| General Safety & Performance | IEC 60601-1 (2005+CORR. 1+CORR. 2), IEC 60601-1-2 ed3.0, IEC 60601-2-25 ed 2.0, IEC 60601-2-49 ed 2.0, IEC 60601-1-11 | Results were satisfactory for all listed standards. |
Study Details:
-
Sample sizes used for the test set and data provenance:
- Spirometry: Not explicitly stated, but the testing was "performed according with American Thoracic Society (ATS) Standards."
- Audiometry: Not explicitly stated.
- ECG Measurements: Not explicitly stated, but involved "three methods: CSE Database Verification, Data Collection, and a Clinical Verification."
- NIBP Device Evaluation: Not explicitly stated, involved "visual inspections and testing."
- Tympanic Thermometer: Not explicitly stated, involved "accuracy testing."
- Low Perfusion SpO2/Pulse Rate Accuracy: Not explicitly stated, involved a "Simulated Low Perfusion Saturation And Pulse Rate Accuracy Study Using A Pulse Simulator."
- Data Provenance: Not specified, but given the nature of the device and testing, it's likely a mix of lab-based/simulated data and potentially clinical data (for ECG clinical verification). The document does not specify country of origin or whether it was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. Ground truth for most tests appears to be based on established industry standards and reference instruments (e.g., ATS standards for spirometry, ANSI/ASA for audiometers, CSE Database for ECG, EN standards for NIBP, and reference devices for temperature/SpO2). For "Clinical Verification" of ECG, it implies expert review, but the number and qualifications are not detailed.
-
Adjudication method for the test set:
- Not explicitly stated. The document simply reports that "results were satisfactory" or "validated" against specified standards or reference data.
-
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:
- No MRMC comparative effectiveness study is mentioned. This device is a vital signs monitor and diagnostic tool, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies involving human readers and AI. The device's functionality is about data acquisition and display, with some automated measurements (like ECG diagnostics for adults, MAP calculation), not interpretation by human readers that would be augmented by AI in the context of a typical MRMC study.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies standalone performance testing against standards for each of its functions (ECG measurements, Spirometry, Audiometry, NIBP, etc.). The device itself performs these measurements or calculations without explicit human intervention in the measurement acquisition and initial processing phase, though a healthcare professional is responsible for operating it and interpreting the results.
-
The type of ground truth used:
- Reference Standards/Devices: For spirometry, ATS standards. For audiometry, ANSI/ASA S3.6-2010. For ECG, CSE Database and clinical verification. For NIBP, EN1060-3. For temperature and SpO2/pulse rate, accuracy testing against reference (simulators or calibrated devices).
- Clinical Verification: Mentioned for ECG, implying comparison to established clinical methods or expert opinion.
-
The sample size for the training set:
- Not applicable/Not mentioned. The document describes a medical device for vital sign measurement and diagnostic tests, not a machine learning or AI algorithm that would typically require a training set in the conventional sense for its core functionality. The "Software Validation" refers to general software engineering principles and risk assessment, not AI model training.
-
How the ground truth for the training set was established:
- Not applicable, as no training set for an AI model is described.
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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 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
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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.
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
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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)
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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 (510) 295-4450 Fax: (510) 246-3293 www.dictumhealth.com Date prepared: July 10, 2017
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 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 |
- 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 |
-
- 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:
- 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.
-
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
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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.
-
- 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 |
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| Dictum Health Inc., IDM100 K152645 | New Device: Dictum Health Inc., IDM100 | |
|---|---|---|
| Indicationsfor Use | The IDM100 for use by clinicians and patients tocollect, store, and transmit general patient healthinformation and patient vital signs data betweenthe patient and a health care professional. TheIDM100 is intended for use on neonate (up to 28days), pediatric (29 days to 12 years), adolescent(>12 years & <18 years) and adult (18 years andolder) populations, in the clinical setting, or aremote location such as home or clinic with theclinician interacting with the patient and/orcaregiver using secured video conferencing. Theproduct is not intended for continuous patientmonitoring.Vital Sign and Cardiopulmonary Tests:• Signal acquisition and display for 12 lead ECGwaveform and 3 lead rhythm: for evaluation anddiagnosis of patient cardiac function.• Non-invasive blood pressure (NIBP):automatically measures systolic and diastolicpressure and pulse rate, as well as calculates anapproximate mean arterial pressure (MAP).• Patient temperature: provides temperaturemeasurements from the tympanic membrane (ear)and manual entry of oral, rectal and axillarytemperatures.• SpO2 Oximeter: for the non-invasivemeasurement of functional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate.• Electronic Stethoscope: for acquiring andmonitoring of auscultation signals from theattached chest piece.• Manual interface for height, weight, respiratoryrate, and other manually captured patientinformation. | The IDM100 is for use by clinicians andpatients to collect, store, and transmit generalpatient health information and patient vitalsigns data between the patient and a healthcare professional. The IDM100 is intended foruse on neonate (up to 28 days), pediatric (29days to 12 years, except as noted below),adolescent (between 13 years and 17 years)and adult (18 years and older) populations, inthe clinical setting, or a remote location suchas home, or clinic, with the clinicianinteracting with the patient and/or caregivervia secured video conferencing. The IDM100 isnot intended for continuous monitoring.Vital Sign and Cardiopulmonary Tests:• Signal acquisition and display for 12 leadECG waveform and 3-lead rhythm forevaluation and diagnosis of patient cardiacfunction. ECG calculation of diagnosticmeasurements is provided for adultpatients only.• Non-invasive blood pressure (NIBP)automatically measures systolic anddiastolic pressure and pulse rate, whilecalculating mean arterial pressure (MAP).The equation used to calculate MAPprovides an approximate value.• Patient temperature provides temperaturemeasurements from the tympanicmembrane (ear) and manual entry of oral,rectal, and axillary temperatures.• SpO2 Oximeter for the non-invasivemeasurement of functional oxygensaturation of arterial hemoglobin (SpO2),pulse rate, and optional Respiratory Rate.• Electronic Stethoscope for acquiring andmonitoring of auscultation signals from theattached chest piece.• Spirometry captures, displays, stores, andcompares pulmonary function measuresand waveforms. The spirometer should onlybe used with patients able to understandand perform the testing instructions.Indicated for use on pediatric, adolescent,and adult patients only. Patients must besix years of age or older. Administration ofthe spirometry test must be performed by ahealth care professional (HCP) who is |
| K170798 | ||
| Dictum Health Inc., IDM100 K152645 | New Device: Dictum Health Inc., IDM100 | |
| physically with the test subject. Spirometrytests are not to be administered by apatient.• Screening hearing test using pure tonemethod. Indicated for pediatric, adolescentand adult only. Patients must be six years ofage or older. The administration of thehearing test must be performed by ahealth care professional (HCP)who isphysically with the test subject. Audiometrytests (hearing tests) are not to beadministered by a patient.• Manual interface for height, weight,respiratory rate, and other manuallycaptured patient information. | ||
| Indications are functionally the same except for added functionality: ECG Measurement, Spirometry, andAudiometry | ||
| ExternalCommunication | Ethernet and Wi-Fi. These two modes aresufficiently ubiquitous to be functionallyequivalent to the predicate. | Ethernet and Wi-Fi. These two modes aresufficiently ubiquitous to be functionallyequivalent to the predicate. |
| UserInterface | 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 |
| Environmentto 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/26cm (Designed for portability, more flexible) | H: 1.5 in/2.6 cm × W: 8 in/21 cm × L: 10 in/26cm (Designed for portability, more flexible) |
| Weight, incl.battery | 3.8 lbs | 3.8 lbs (SAME) |
| 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) |
| Protectionagainstelectric 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 | |
| Prescriptionor OTC | Prescription | Prescription (Same) |
| Additionalmodes | Not applicable | ECG QRS Measurement, Spirometry,Audiometry |
| Power | Rechargeable Battery, 4.5 hour (Adequate foruse, warning message when power reserve isat 20% or lower) | SAME |
| BatteryRecharge | From AC Line, < 3 hours. | SAME |
| Spirometry Substantial Equivalence | ||
| Spirobank G, K072979 MIR MedicalInternational Research | New Device: Dictum Health Inc., IDM100 | |
| Indications | The Spirobank G spirometer is intended to beused by a physician or by a patient under theinstruction of a physician or paramedic. Thedevice is intended to test lung function andcan make spirometry testing in people of allages, excluding infiants and neonates.It can be used in any setting. | Spirometry for lung capacity evaluation (FVC).Indicated for use on pediatric, adolescent, andadult patients only. Patients must be six yearsof age or above and capable of performing thetest. (This is equivalent to the predicate sinceinfants and neonates cannot cooperate withthe testing.) |
| Functions | Graphic display, USB, Bluetooth | SAME |
| Testing | Spirometry testing was performed accordingwith American Thoracic Society (ATS)Standards. The results obtained were withinthe range of accuracy required by ATS. | SAME |
| Safety | IEC 60601-1 Standard, this product and itscomponent parts are of type BF. EMC per IEC60601-1-2 | SAME |
| OperatingEnvironment | Designed for use in a doctor's office, in ahospital or directly by the patient during day-to-day activities for the monitoring of physicalconditions. Can be used in any environment. | SAME |
| Sensor | Reusable or disposable | Single patient use disposable only |
| Power | Battery (disposable) | Battery (rechargeable) |
| Fundamentalunderlyingtechnology | Bi-directional digital turbine using Infraredinterruption. | Honeywell pressure sensor in the range of theGeratherm flow transducer measures thedifferential pressure and converts it todigitized data. |
| Flow range | ± 16 L/s | ± 14 L/s Meets ATS guideline |
| FVC Forced Vital Capacity (L) | SAME | |
| Tests | FEV1 Volume expired in the 1st second of the test(L) | SAME |
| FEV1/FVC FEV1/FVC x 100 % | SAME | |
| Dictum Health Inc., IDM100 K152645 | New Device: Dictum Health Inc., IDM100 | |
| PEF Peak expiratory flow L/s | SAME | |
| FET Forced expiratory time s | SAME | |
| FIVC Forced inspiratory volume (L) | SAME | |
| PIF Peak inspiratory flow L/s | SAME |
5. Comparison with predicate devices – IFU and Technological characteristics.
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-
- Safety and Effectiveness: The IDM labeling contains instructions for use and necessary cautions, warnings and notes to allow for use of the device as intended. 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 (or exempt) medical devices. Clearance numbers for provided accessories are provide in the description section (4) above.
-
- 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, Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems; Results were satisfactory.
- f. Design validation (usability study) for the IMD100 indications for use in clinical and non-clinical settings. Results were satisfactory.
- Additional mode validation: Audiometery. Tested to ANSI/ASA S3.6-2010: Specification for ம் Audiometers. Results were satisfactory.
- h. Additional mode validation: ECG Measurements were validated with three methods: CSE Database Verification, Data Collection, and a Clinical Verification.
- i. Additional mode validation: Spirometry, evaluated according to ATS/ERS Task Force Standardisation of Lung Function Testing: Standardisation of spirometry (2005). Results were satisfactory. Biocompatibility test reports were obtained and reviewed (cytotoxicity, irritation, and sensitization) for the patient contact sensor and were satisfactory. Human factors usability testing was also successfully conducted.
- Standards testing protocols per the following list of standards: (Results were satisfactory.) j.
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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 basic safety 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 - CollateralStandard: Electromagnetic disturbances - Requirements and tests | 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) | Partial Simulation Performance Test Procedure, Packaged-Products 150 lb(68 kg) or Less Standard Practice for Performance Testing of ShippingContainers and Systems | 2011 |
| ASTM D4169-14 | Containers and Systems |
-
- Clinical Testing: Not applicable.
-
- Conclusion: The IDM100 has the same intended use as the predicate device except for the added modes, which we have validated. Test results demonstrate that the device is as safe and effective as the predicate device (K152645). 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).