DynoSense Vital Sign Measuring System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 2, 2019 DynoSense Corp. Saeed Azimi CEO 15166 Los Gatos Blvd Los Gatos, California 95032 Re: K190090 Trade/Device Name: DynoSense Vital Sign Measuring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DOA, DPS, FLL, DRT, MNR Dated: June 27, 2019 Received: July 2, 2019 Dear Saeed Azimi: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190090 Device Name Dynosense Vital Sign Measuring System ### Indications for Use (Describe) The DynoSense Vital Sign Measuring System is intended to record, transfer, store and display of single lead electrocardiography (ECG), heart rate (HR), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), and oral body temperature (TEMP). The device comes in contact with the patient for approximately 60 seconds at each use. This system is for spot checking and does not have continuous monitoring capability or any alarm features. This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition. This system makes no specific diagnosis. The device is for single patient use. Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.6 2.4L2.4 13.6M2.4 2.4L13.6 13.6" stroke="#000000" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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 PRAStaff@fda.hhs.gov "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}------------------------------------------------ # 510(K) SUMMARY In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the DynoSense Vital Sign Measuring System is provided below: | Device Common Name: | Monitor, Physiological, Patient (Without Arrhythmia<br>Detection or Alarms) | |----------------------------|---------------------------------------------------------------------------------------------------------------| | Device Trade Name: | DynoSense Vital Sign Measurement System | | Applicant: | DynoSense Corp.<br>15166 Los Gatos Blvd<br>Los Gatos, CA 95032 | | Contact: | Saeed Azimi<br>CEO<br>DynoSense Corp<br>sazimi@dynosense.com<br>Phone: (650) 397-6105<br>Fax: (650) 397-6013 | | Prepared by: | Saeed Azimi<br>DynoSense Corp<br>(650) 397-6013<br>sazimi@dynosense.com | | Date Prepared: | December 24th, 2018 | | Classification Regulation: | 870.2300, Class II | | Classification Name: | Cardiac monitor (including cardiotachometer and rate<br>alarm) | | Panel: | Cardiovascular | | Primary Product Code: | MWI | | Secondary Product Codes: | DQA, DPS, FLL, DRT, MNR | | Predicate Devices: | Primary: CheckMe Pro Health Monitor (K150869)<br>Secondary: Welch Allyn Spot Vital Signs Monitor<br>(K132808) | {4}------------------------------------------------ # K190090 ## Page 2 of 8 # Reference Devices: - ABL-90 FLEX (K120197) - · Fluke ProSim 8 Vital Simulator (K110429) - · Nellcor Bedside SpO2 Patient Monitoring System (K142865) - · Capnostream20p (K101995) - · Welch Allyn Spot Vital Signs Monitor (K022163) - · MEDI-TRACE(R) 500 ECG ELECTRODE (K945479) - · EDAN PC-ECG SE1010 EKG (K131819) #### INDICATIONS FOR USE: 1. "The DynoSense Vital Sign Measuring System is intended to record, transfer, store and display of single lead electrocardiography (ECG). heart rate (HR). functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), and oral body temperature (TEMP). The device comes in contact with the patient for approximately 60 seconds at each use. This system is for spot checking and does not have continuous monitoring capability or any alarm features. This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition. This system makes no specific diagnosis. The device is for single patient use. Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device." #### DEVICE DESCRIPTION: 2. The DynoSense Vital Sign Measuring System is a battery-powered, handheld, personalized single patient use vital sign measuring apparatus. The user must hold the Device with their left hand. Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements are based on transmittance of light through the index finger. Respiration rate (RR) measurements are based on pressure change at the aperture opening during breathing. Oral temperature (TEMP) is measured via sublingual and lingual contact with the thermometer tip. ECG and heart rate (HR) measurements are obtained via completing an electrical path across the left side of the chest. Vital sign data are communicated to a Bluetooth-capable mobile platform for forwarding to the cloud application for processing and storage. #### STERILIZATION, SHELF LIFE, CLEANING, REUSE: 3. The System is delivered and used non-sterile. The System is intended to be single patient-only, and reusable. {5}------------------------------------------------ #### 4. BIOCOMPATIBILITY: The System is a surface device and only includes components which are for limited contact (≤ 24h) and are either intact skin-contacting or mucosal membrane-contacting. The materials were tested in accordance with ISO 10993. #### PERFORMANCE DATA: 5. The following performance testing was provided to support the substantial equivalence of the subject device: - ECG and Heart Rate Measurements: To validate the ability of the System to produce ECG . waveform and heart rate measurements, bench agreement testing as per ISO 60601-2-47:2012. The ECG and Heart Rate algorithm tested according to the requirements of IEC 60601-2-47. - SpO2 Measurements: To validate the ability of the System to make pulse oximetry ● measurements, a clinical agreement study was conducted, as per ISO 80601-2-61:2011. - . Pulse Rate Measurements: To validate the ability of the System to make pulse rate measurements a bench agreement study between the System and a pulse rate simulator was performed, and clinical agreement study was performed. Both studies were conducted per ISO 80601-2-61:2011. - Respiration Rate Measurements: To validate the ability of the System to calculate a ● respiration rate, a clinical agreement study was conducted. - Temperature Measurements: To validate temperature measurements, a clinical agreement study was conducted, as per ISO 80601-2-56:2012. - Usability: Testing was conducted to evaluating the ability of laypeople to read and understand the System instructions for use, and subsequently simulate normal use of the System without prior training. #### SOFTWARE DOCUMENTATION: 6. Software documentation for a Moderate Level of Concern device is provided in support of the System. #### ELECTRICAL SAFETY TESTING: 7. The DynoSense Vital Signs Measuring System was evaluated as per ANSI / AAMI 60601-1:2005 + A1:2012, and found to be compliant. #### ELECTROMAGNETIC COMPATIBILITY TESTING: 8. The DynoSense Vital Signs Measuring System was evaluated as per IEC 60601-1-2:2014, and found to be compliant. {6}------------------------------------------------ # K190090 Page 4 of 8 #### 9. STANDARDS: Table 1 provides the complete list of standards that are used in the 510(k) to establish device performance and support substantial equivalence: | Standard | Title | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within<br>a risk management process | | ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro<br>Cytotoxicity | | ISO 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin<br>sensitization; | | ISO 10993-12:2012 | Biological Evaluation of Medical Devices - Part 12: Sample preparation and<br>reference materials | | AAMI / ANSI 60601-<br>1:2005 + A1:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and<br>essential performance | | IEC 60601-1-11: 2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety<br>and essential performance -- Collateral standard: Requirements for medical<br>electrical equipment and medical electrical systems used in the home healthcare<br>environment | | IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for basic safety<br>and essential performance - Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests | | IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety<br>and essential performance - Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests | | AAMI / ANSI 60601-<br>2-47:2012 | Medical electrical equipment - Part 2-47: Particular requirements for the basic<br>safety and essential performance of ambulatory electrocardiographic systems | | AAMI / ANSI 60601-<br>2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic<br>safety and essential performance of multifunction patient monitoring equipment | | ISO 80601-2-56:2012 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety<br>and essential performance of clinical thermometers for body temperature<br>measurement | | ISO 80601-2-61:2011 | Medical electrical equipment - Particular requirements for basic safety and<br>essential performance of pulse oximeter equipment. | List of Standards Table 1: {7}------------------------------------------------ #### 10. SUBSTANTIAL EQUIVALENCE DISCUSSION The primary predicate device is the CheckMe Pro Health Monitor (cleared under K150869); the secondary predicate device is the Welch Allyn Spot Vital Signs Monitor (cleared under K 132808; this device is also a reference device for temperature measurement validation). | Technological Comparison | | | Substantial Equivalence<br>to Predicate device | | |----------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------| | | Subject Device | Predicate Device | | | | 510(k) Number | Unknown | K150869 | NA | | | Applicant | DynoSense Corp. | Viatom Technology Co.<br>Ltd. | NA | | | Device Name | DynoSense Vital Sign<br>Measuring System | Checkme Pro Health<br>Monitor | NA | | | Classification<br>Regulation | 870.2300 –<br>Physiological Patient<br>Monitor | 870.2300 – Physiological<br>Patient Monitor | Same | | | Physiological<br>Parameters<br>Monitored | ECG, HR, SpO2, PR,<br>Respiration Rate<br>(RR), Temperature | ECG, HR, SpO2,<br>Temperature | Similar | | | Location | Home | Home and Hospital | Subject device only<br>supports Home Use | | | Rx or OTC | Rx | Rx | Same | | | Power Supply | Rechargeable<br>Lithium-Polymer<br>battery 210 mAh | 560mAh rechargeable<br>lithium-ion polymer<br>battery | Similar | | | Alarm | No Alarm | No Alarm | Same | | | Data collection<br>memory | Essentially unlimited<br>storage in cloud | 100 measurements<br>storage | Better | | | Operating modes | Spot-Check | Continuous Recording<br>and Spot-Check | Subject device only<br>supports Spot-check | | | Comparison of ECG Measurements | | | | | | Measured ECG<br>Parameter | ECG waveform, Heart<br>Rate (HR) | ECG waveform, Heart<br>Rate (HR) | Same | | | ECG Rhythm<br>Classification | Not included | Not included | Same | | | ECG Lead Type | Single Lead, 3<br>Contacts | External ECG<br>Cable and<br>Electrodes | Similar | | | Input impedance | >10 M Ohm | > 10 M Ohm | Same | | | Technological Comparison | | | Substantial Equivalence<br>to Predicate device | | | | Subject Device | Predicate Device | | | | Input dynamic<br>range | ±300mV | ±3 mV | Better | | | Bandwidth | 0.67 to 40 Hz | 0.05 — 40<br>Hz | Same | | | A/D conversion | 24 bit | 16 bit | Better | | | Sampling Rate | 500 Hz | 500 Hz | Same | | | Measurement<br>Time | <60 seconds | 30 seconds | Similar | | | Display | Not included | 400*240 Dot-matrix LCD<br>display | NA | | | Input | Dry conductive<br>electrodes | Dry conduction electrodes<br>and/or external auxiliary<br>electrodes | Similar | | | Heart rate Range | 30〜250 bpm | 30〜250 bpm | Same | | | Heart rate<br>Accuracy | ±2 bpm or ± 2%,<br>whichever is larger | ±2 bpm or ±2%, whichever<br>is larger | Same | | | Comparison of SpO2 Measurements | | | | | | Display Data | SpO2, Pulse Rate (PR) | SpO2, Pulse Rate (PR) | | Same | | Mode | Spot-Check | Continuous Recording<br>and Spot-Check | | Subject device supports<br>Spot-check only | | Sensor Types | Integrated | Integrated and external | | Subject device supports<br>integrated sensor only | | Population | Patients ≥18 years of<br>age | Adult and Pediatric<br>(continuous recording only<br>for adult) | | Subject device supports<br>patients ≥18 years of age | | SpO2 Display<br>Range | 0% to 100% | 0 - 100% | | Same | | SpO2 Accuracy | 70%-100% ±2% | 70%-100%<br>±3% | 70%-100%<br>±2% | Similar | | SpO2 Resolution | 1 % | 1 % | | Same | | PR range | 30-250 bpm | 30-250 BPM | | Same | | PR Accuracy | ±2 bpm or ±2%,<br>whichever is greater | ±2 bpm or ±2%, whichever<br>is greater | | Same | | PR Resolution | 1 bpm | 1 bpm | | Same | | Comparison of Temperature Measurement and Analysis | | | | | | Measurement<br>Technique | Thermo-resistive<br>sensor | infrared sensor<br>(thermopile) | | Same | | Technological Comparison | | | | | | | Subject Device | Predicate Device | Substantial Equivalence<br>to Predicate device | | | Measurement<br>site | Oral | Forehead | Subject device only<br>supports Oral | | | Mode | Predictive (Normal)<br>Mode | Direct (Monitor) Mode | Subject device only<br>supports Predictive<br>(Normal) mode | | | Unit | °C/°F | °F | Subject device only<br>supports °F | | | Measuring range | $30.0° C - 43.0 ° C$ | $33.8 ° C - 42.2 ° C(93.2°F to 108.0°F)$ | Subject device supports<br>wider range | | | Calibration<br>Accuracy | ± 0.2° C (Adjusted<br>mode) | ± 0.2° C (±0.4°F) | Similar | | #### Table 2: Technological Comparison, System vs. CheckMe Pro {8}------------------------------------------------ {9}------------------------------------------------ K190090 Page 7 of 8 | Table 3: | Technological Comparison, System vs. Welch Allyn Connex Vital Signs Monitor | |----------|-----------------------------------------------------------------------------| |----------|-----------------------------------------------------------------------------| | Comparison of Respiration Rate Measurement | | | | |--------------------------------------------|------------------------------------------------|---------------------------------------------|------------------------------------------------------| | 510(k) Number | Unknown | K132808 | NA | | Applicant | DynoSense Corp. | Welch Allyn, Inc. | NA | | Device Name | DynoSense Vital Sign<br>Measuring System | Connex Vital Signs<br>Monitor | NA | | Classification<br>Regulation | 870.2300 –<br>Physiological Patient<br>Monitor | 870.2300 – Physiological<br>Patient Monitor | NA | | Location | Oral | Oral | Same | | Measurement<br>Technique | Pressure based | Partial pressure-based | Similar | | Location | Home | Hospital | Testing conducted on the<br>System supports home use | | Display Range | 4 bpm – 50 bpm | 4 bpm – 70 bpm | System supports narrower<br>range | | Measurement<br>Range | 4 bpm – 50 bpm | 6 bpm – 45 bpm | Better | | Accuracy | ± 1.5 bpm, or ± 4%,<br>whichever is greater | ± 1.5 bpm, or ± 4%,<br>whichever is greater | Same | #### SUBSTANTIAL EQUIVALENCE CONCLUSION 11. Based on the detailed comparison of specifications to the previously cleared CheckMe Pro Health Monitor (K150869) and the Welch Allyn device (K132808), the functional, performance and clinical testing and conformance with applicable standards as well as the comparison of {10}------------------------------------------------ indications, the differences do not raise new questions of safety and effectiveness and the DynoSense Vital Signs Measuring System can be found substantially equivalent to the predicate device.