(127 days)
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal.
The Vitals360® capabilities include storing, displaying measuring data.
This document describes the regulatory submission for the Vitals360® Multi-Vitals Mobile Monitor (K210086). The device is intended for measuring, displaying, reviewing, and storing non-invasive blood pressure (NIBP), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), and ECG in adults 18 years of age and older.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a single table of acceptance criteria and specific reported device performance in a dedicated section with pass/fail outcomes. Instead, it describes performance characteristics and accuracies within the "Comparison to the Predicate Device" section and lists the standards to which clinical studies were conducted under "Performance Data."
Based on the information provided, we can infer the acceptance criteria for individual parameters from the device's specifications and the adherence to relevant ISO standards for medical devices. The "reported device performance" is essentially the device's stated specifications and accuracies.
| Parameter | Acceptance Criteria (Implied from stated device performance and predicate comparison) | Reported Device Performance (Vitals360®) |
|---|---|---|
| SpO2 Accuracy | Should be comparable to or better than predicate (±3% for 70%-100% range) | Displayed range: 70% |
| Pulse Rate Range | Comparable to predicate (30 bpm-240 bpm) | 30 to 150 bpm |
| Pulse Rate Accuracy | Comparable to predicate (±2bpm or ±2%, whichever is greater) | ±2bpm or ±2%, whichever is greater |
| NIBP Accuracy | Mean deviation values: ±5 mmHg. Standard deviation <= 8 mmHg (Consistent with predicate) | Mean deviation values: ±5 mmHg. Standard deviation <= 8 mmHg. |
| NIBP PressureRange - Systolic | Comparable to predicate (60 mmHg - 255 mmHg) | 60 mmHg ~230mmHg |
| NIBP PressureRange - Diastolic | Comparable to predicate (30 mmHg - 195 mmHg) | 40 mmHg ~130mmHg |
| Temperature Range | Comparable to predicates (e.g., 32.0°C to 43.0°C) | 34.0°C |
| Temperature Accuracy | Comparable to predicates (e.g., ±0.2°C for 36.0°C to 39.0°C, ±0.3°C other range) | ±0.3°C (±0.5°F) |
| ECG Heart Rate Range | Comparable to predicate (30bpm-240bpm) | 30bpm-240bpm |
| ECG Heart Rate Precision | Comparable to predicate (±2bpm or ±2%, whichever is greater) | ±2bpm or ±2%, whichever is greater |
The claims of "substantial equivalence" imply that these reported performances met the criteria required for comparison to the predicate devices and relevant standards.
2. Sample size used for the test set and the data provenance
The document states: "Clinical studies were conducted to verify the accuracy of proposed device." and "Clinical testing has been performed under an approved protocol with subject informed consent. Clinical test results support device accuracy claims for the specified measurement range."
However, the specific sample sizes for the test sets are not explicitly stated in the provided text. The data provenance is generally clinical studies for verification, implying human subjects. The country of origin of the data and whether the studies were retrospective or prospective are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication method for the test set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. 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
The Vitals360® device is a medical monitoring device, not an AI-assisted diagnostic imaging tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not conducted for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the inherent accuracy of the device's measurements (SpO2, NIBP, TEMP, PR, ECG). The document states that "Clinical studies were conducted to verify the accuracy of proposed device" and lists ISO standards that govern the accuracy and performance of such medical devices. This implicitly means that the device's standalone performance, i.e., its ability to accurately measure these physiological parameters, was evaluated. The reported accuracies (e.g., for SpO2, NIBP, Pulse Rate, Temperature) represent the standalone performance of the device's algorithms and sensors.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a monitoring device measuring vital signs, the ground truth is typically established by:
- Reference standard devices: Using highly accurate and calibrated medical equipment as the gold standard for comparison (e.g., a clinically validated sphygmomanometer for NIBP, a co-oximeter for SpO2, or a precision thermometer for temperature).
- Direct physiological measurements: For parameters like ECG, the ground truth would be the actual electrical activity of the heart as captured by a reference ECG system.
The document states that clinical studies were performed according to standards like ISO 80601-2-61 (Pulse Oximeter), ISO 81060-2 (Non-invasive sphygmomanometers), and ISO 80601-2-56 (clinical thermometers). These standards outline the methods for establishing ground truth for each specific parameter, typically involving comparisons to reference devices or established physiological measurements. While not explicitly detailed in the text, adherence to these standards implies the use of appropriate ground truth methods.
8. The sample size for the training set
The Vitals360® is a vital signs monitor, not typically an AI/machine learning device that requires a "training set" in the conventional sense for a diagnostic algorithm. Its performance relies on established physical principles of measurement (e.g., oscillometric for NIBP, photoelectric for SpO2, infrared for temp) and signal processing. Therefore, the concept of a "training set" from the perspective of teaching an AI model is not applicable to this device.
9. How the ground truth for the training set was established
As explained in point 8, the concept of a "training set" for an AI model is not applicable to this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2021
VoCare, Inc. Deon Vigilance Chief Medical Officer 4950 Turkev Foot Road Zionsville, Indiana 46077
Re: K210086
Trade/Device Name: Vitals360® Multi-Vitals Mobile Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DSH, DXN, FLL Dated: April 19, 2021 Received: April 19, 2021
Dear Deon Vigilance:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,
for
LT 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
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Indications for Use
510(k) Number (if known) K210086
Device Name
Vitals360® Multi-Vitals Mobile Monitor
Indications for Use (Describe)
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY - K210086
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
I. SUBMITTER
Contact Person: Steve Peabody VoCare, Inc. 4950 Turkey Foot Road Zionsville, IN 46077 USA Tel: +1 (317) 658-0005 Fax: N/A Submission Contact: Deon Vigilance Date Prepared: April 15, 2021
II. DEVICE
| Name of Device: | Vitals360® Multi-Vitals Mobile Monitor – Model: VC-001 |
|---|---|
| Classification Name: | Monitor, Physiological, Patient (Without Arrhythmia Detection OnAlarms) |
| Regulation: | 21 CFR §870.2300 |
| Regulatory Class: | Class II |
| Product Classification Code: | MWI, DQA, DSH, DXN, and FLL |
PREDICATE DEVICE III.
| Primary Predicate Manufacturer: | Shenzhen Creative Industry Co., Ltd. |
|---|---|
| Primary Predicate Trade Name: | All-in-One Health Monitor, PC-303 |
| Primary Predicate 510(k): | K170047 |
| Secondary Predicate Manufacturer: | Ningbo Ranor Medical Science & Technology Co., Ltd. |
|---|---|
| Secondary Predicate Trade Name: | Infrared Thermometer, RN-50A, RN-50B |
| Secondary Predicate 510(k): | K200578 |
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It
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can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal.
The Vitals360® capabilities include storing, displaying measuring data.
INTENDED USE & INDICATION FOR USE V.
Vitals360® device is intended to be used for measuring, displaying and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 vears of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
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COMPARISON TO THE PREDICATE DEVICE VI.
| Features | Subject Device - Vitals360 | Primary Predicate Device - PC-303 (K170047) | Secondary Predicate Device -Infrared Thermometer RN-50A, RN-50B (K200578) | Justification for Differences |
|---|---|---|---|---|
| Applicant | VoCare Inc. | Shenzhen Creative IndustryCo., Ltd. | Ningbo Ranor Medical Science& Technology Co., Ltd. | N/A |
| ClassificationRegulation | 21 CRF 870.2300 | 21 CRF 870.2300 | 21 CFR 880.2910 | The secondary predicate islimited to the regulation forclinical thermometers. |
| Classificationand Code | Class II, MWI, DQA, DSH,DXN, and FLL | Class II, MWI, DQA, DXN,FLL, NBW, DSH | Class II, FLL | The subject device does notinclude a glucometer function,and therefore the NBW code isnot applicable to the subjectdevice. The secondary predicateis limited to the clinicalthermometer product code. |
| Common name | Patient Monitor | Patient Monitor | Thermometer, electronic, clinical | The secondary predicate islimited to the clinicalthermometer function. |
| Intended use | Vitals360® device is intended tobe used for measuring,displaying, reviewing and storingof non-invasive blood pressure(NIBP), non-invasive monitoringof functional oxygen saturationof arterial hemoglobin (SpO2),pulse rate (PR), foreheadtemperature (TEMP), ECG,weight and height in adults noless than 18 years of age.This VITALS360® device isintended for use by trained adultsonly who can use smartphones | The All-in-One HealthMonitor, PC- 303 is a devicedesigned for spot- checkingmeasuring of the patient'sphysiological parameters, suchas Non-Invasive BloodPressure (NIBP), Oxygensaturation (SpO2), Pulse Rate(PR) and Body Temperature(TEMP);Additionally, the device isavailable to communicate withthe compatible Blood GlucoseMonitoring System and ECG | The Infrared thermometer is anon-contact infraredthermometer intended for theintermittent measurement ofhuman body temperaturefrom forehead for people ofall ages. The device isreusable for home use andclinical use. | The subject device is limitedto patients 18 years of ageand older and does notinclude indications forglucose measurement. Theseomissions do not introduceany additional risks, andotherwise the indications areequivalent to the primarypredicate. The secondarypredicate is limited to bodytemperature measurement andalso applies to a wider patientrange. |
| proficiently.This VITALS360® device isintended for use in a clinical orhome environment.This VITALS360® device isa reusable device followingthorough cleaning betweenuses. | monitor to make themeasurement.This device is applicable forAdult and Pediatric (age≥3years old) use in clinicalinstitutions and has noconditions or factors ofcontraindication. | |||
| Physicaldimension(mm)/weight(kg) | 145(L) × 80(W) × 25(H) / 0.25kg | 165(L) × 96(W) × 68(H) / 0.44kg | N/A | The subject device is smaller thanthe primary predicate which doesnot create any negative issuesregarding portability or usabilityof the device, and the smallersize of the clinical thermometeris due to its limited functionality. |
| Display | 3.66 inch | 4.3 inch | LCD Display | The display size of the subjectdevice and the predicate areequivalent, and no readabilityissues were identified duringusability testing. The LCDdisplay for the clinicalthermometer is appropriate onlyfor the display of a singletemperature. |
| Type, Degree ofprotectionagainst electricshock | Class II with internal electricpower supply.SpO2/NIBP/TEMP: Type BFapplied part. | Class II with internal electricpower supply.SpO2/NIBP/TEMP: Type BFapplied part. | Class II with internal electricpower supply.TEMP: Type BF applied part. | The subject device and theprimary predicate are identical.The applicable applied part of thesubject device is also equivalentto the clinical thermometer. |
| Power supply | Battery or AC | Battery or AC | Battery | The subject device and theprimary predicate are identical.The lack of AC charging for theclinical thermometer isappropriate for the lower powerrequirements. |
| Powerrequirement | (100-240) VAC, 50/60Hz, 0.5A,Rechargeable lithium battery,3.7VDC | (100-240) VAC, 50/60Hz,15VA,Rechargeable lithium battery,3.7VDC | AAA*3, DC 3V | The subject device and theprimary predicate are equivalent.The lack of AC charging for theclinical thermometer isappropriate for the lower powerrequirements. |
| Alarm | No alarm | No alarm | Low Battery Indication | The subject device and primarypredicate do not include alarmsfor low battery indication,because the display is able toshow a battery icon that indicatesthe remaining battery % and thedevice will not takemeasurements if the battery levelis too low. |
| Features | Subject Device - Vitals360 | Primary Predicate Device -PC-303 (K170047) | Secondary Predicate Device -Infrared Thermometer RN-50A, RN-50B (K200578) | Justification for Differences |
| SpO2 / Pulse Rate | ||||
| Patient | 18 years and older | Adult, pediatric | Adult, pediatric | The subject device is limited topatients 18 years of age andolder, while both predicates areindicated for adult and pediatricpatients. This omission does notintroduce any additional risks. |
| SpO2measurementaccuracy | Displayed range: 70% | Displayed range: 70%~100%±3% (during 70%-100%)Undefined (during 0-70%) | N/A | Subject device and primarypredicate are equivalent, andsecondary predicate does notinclude SpO2 feature. |
| Pulse ratemeasurementrange | 30 to 150 bpm | 30 bpm-240 bpm | N/A | Subject device and primarypredicate are equivalent, andsecondary predicate does notinclude SpO2 feature. |
| Pulse rateaccuracy | ±2bpm or ±2%, whichever isgreater | ±2bpm or ±2% (whichever isgreater) | N/A | Subject device and primarypredicate are identical, and |
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| secondary predicate does notinclude SpO2 feature. | ||||
|---|---|---|---|---|
| Alarm | No alarm | No alarm | N/A | Subject device and primarypredicate are identical, andsecondary predicate does notinclude SpO2 feature. |
| Features | Subject Device - Vitals360 | Primary Predicate Device - PC-303 (K170047) | Secondary Predicate Device -Infrared Thermometer RN-50A, RN-50B (K200578) | Justification for Differences |
|---|---|---|---|---|
| NIBP | ||||
| Method | Oscillometric method | Oscillometric method | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Patient type | 18 years and older | Adult and Pediatric patients | N/A | The subject device is limited to patients 18 years of age and older and does not include indications for glucose measurement. These omissions do not introduce any additional risks, and otherwise the indications are equivalent to the primary predicate. The secondary predicate does not include NIBP feature. |
| Unit of measure | mmHg & kPa | mmHg & kPa | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Pressure measurement range - Systolic | 60 mmHg ~230mmHg | 60 mmHg - 255mmHg | N/A | Subject device and primary predicate are equivalent, and secondary predicate does not include NIBP feature. |
| Pressure measurement range - Diastolic | 40 mmHg ~130mmHg | 30 mmHg - 195mmHg | N/A | Subject device and primary predicate are equivalent, and secondary predicate does not |
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| include NIBP feature. | ||||
|---|---|---|---|---|
| BP accuracy | Mean deviation values: ±5 mmHg.Standard deviation <= 8 mmHg. | Mean deviation values: ±5 mmHg.Standard deviation <= 8 mmHg. | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Cuff pressure range | 0 to 300mmHg | 0 to 300mmHg | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature. |
| Over pressure protector | Cuff pressure exceeds300mmHg at any time. | Cuff pressure exceeds 300mmHg (Adult and pediatric mode) at any time. | N/A | Subject device is limited to subjects 18 years an older, while the primary predicate is indicated for adult and pediatric patients. The secondary predicate does not include NIBP feature. |
| Alarm | No alarm | No alarm | N/A | Subject device and primary predicate are identical, and secondary predicate does not include NIBP feature |
| Features | Subject Device - Vitals360 | Primary Predicate Device -PC-303 (K170047) | Secondary Predicate Device -Infrared Thermometer RN-50A, RN-50B (K200578) | Justification for Differences |
|---|---|---|---|---|
| TEMP | ||||
| Fundamentalscientifictechnology | Infrared technology | Infrared technology | Infrared technology | All three devices are identical with regard to technology. |
| Patient type | 18 years and older | Adult, Pediatric | Adult, Pediatric | The subject device is limited to patients 18 years of age and older, while both predicates are indicated for adult and pediatric patients. This omission does not |
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| introduce any additional risks. | ||||
|---|---|---|---|---|
| Unit of measure | °C or °F | °C or °F | °C or °F | All three devices are identicalwith regard to unit of measure. |
| Measurementsite | Forehead | Ear | Forehead | The secondary predicate wasselected, because the primarypredicate uses a differentmeasurement site. The secondarypredicate and the subject deviceare identical with regard tomeasurement site. |
| Temperaturemeasurementrange | 34.0°C | 32.0°C to 43.0°C (90°F to109.4°F) | 32.0°C | The temperature ranges of allthree devices are slightlydifferent, but they are equivalentand meet the requirements of theapplicable standards for clinicalthermometers. |
| Temperaturemeasurementaccuracy | ±0.3°C (±0.5°F) | ±0.2°C (36.0°C to 39.0°C),±0.3°C other range | ±0.2°C (36.0°C to 39.0°C)±0.3°C other range | The temperature accuracy of thesubject device is equivalent toboth predicates, and all threedevices meet the requirements ofthe clinical thermometerstandards. |
| Features | Subject Device - Vitals360 | Primary Predicate Device -PC-303 (K170047) | Secondary Predicate Device -Infrared Thermometer RN-50A, RN-50B (K200578) | Justification for Differences |
|---|---|---|---|---|
| ECG | ||||
| Patient type | 18 years and older | Adult, pediatric patients | N/A | The subject device is limited topatients 18 years of age andolder, while both predicates areindicated for adult and pediatricpatients. This omission does notintroduce any additional risks. |
| Number ofelectrodesemployed | 2 embedded metal electrodes | 3 embedded metal electrodes orusing 3 adhesive ECGelectrodes by | N/A | Subject device and primarypredicate are equivalent, andsecondary predicate does not |
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| connection to the lead wire | include ECG feature. | |||
|---|---|---|---|---|
| Heart ratemeasuringrange | 30bpm-240bpm | 30bpm-240bpm | N/A | Subject device and primarypredicate are identical, andsecondary predicate does notinclude ECG feature. |
| Resolution | 1bpm | 1bpm | N/A | Subject device and primarypredicate are identical, andsecondary predicate does notinclude ECG feature. |
| Heart ratemeasuringprecision | ±2bpm or ±2%, whichever isgreater | ±2bpm or ±2%, whichever isgreater | N/A | Subject device and primarypredicate are identical, andsecondary predicate does notinclude ECG feature. |
| Sweep speed | 25mm/s, 50mm/s | 20mm/s±10% | N/A | Subject device and primarypredicate are equivalent, andsecondary predicate does notinclude ECG feature. |
| Signalbandwidth | 0.67Hz-40Hz | 0.5Hz-40Hz | N/A | Subject device and primarypredicate are equivalent, andsecondary predicate does notinclude ECG feature. |
| Internal noiselevel | ≤50uV p-v | ≤30uVp-p | N/A | Subject device and primarypredicate are equivalent, andsecondary predicate does notinclude ECG feature. |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for VC-001 was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- . Irritation
The subject devices are considered surface contacting for a duration of not exceed 24 hours.
Non-clinical data
The Pulse Oximeter has been tested according to the following standards:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- IEC 60601-1-11: 2015 Part 1-11: General requirements for basic safety and essential performance-Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-2-47: 2012 Medical Electrical Equipment Part 2-61: Particular Requirements for Basic . Safety and Essential Performance of ambulatory electrocardiographic systems.
- ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- . ISO 80601-2-30: 2018 Medical Electrical Equipment - Part 2-30: Particular Requirements for Basic Safety and Essential Performance of automated non-invasive sphygmomanometers.
- ISO 80601-2-56: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of clinical thermometers for body temperature measurement.
- . IEC 62133: 2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
The test was selected to show substantial equivalence between the subject device and the predicate.
Clinical data
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
- . ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
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- . Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff
- . ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
- . ISO 80601-2-56: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of clinical thermometers for body temperature measurement.
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical test results support device accuracy claims for the specified measurement range.
VIII. CONCLUSION
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate devices.
§ 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).